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Align® FAQ: Frequently
Asked Questions

Find answers to the most frequently asked questions regarding Align.
General Information Questions

Taking Align Questions

Health/Safety Questions

Where-to-Buy Questions

Miscellaneous Questions

Ingredients Questions

General Information Questions

What is Align?
Align is a daily probiotic supplement that helps promote a healthy digestive system.* When taken daily, Align works by supplementing your digestive system with healthy bacteria to help support your digestive balance.*

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Is Align a laxative?
No, Align is a daily probiotic supplement that works naturally to help build and maintain a strong, healthy digestive system.*



Is Align an antacid?
No, Align is a daily probiotic supplement that works naturally to help build and maintain a strong, healthy digestive system.*



What is normal, healthy bowel function?
Gastroenterologists say that healthy, normal bowel function can range from three bowel movements per day to three bowel movements per week. Because the definition of normal bowel function varies from person to person, you may want to talk to your doctor about what is normal for you. Align is intended for people who are interested in building and maintaining a healthy digestive system.*



Why do I need Align?
Your body needs good bacteria ("probiotics") for a number of things, including healthy digestion. But these bacteria are fragile. When you were very young, most of the bacteria in your digestive system were good Bifidobacteria. Common issues such as changes in diet and schedule, stress, and travel can disrupt your natural balance of good bacteria. Bifantis, the probiotic ingredient in Align, supplements your system with natural good bacteria.* When taken daily, Align helps promote a healthy digestive system.*



Who should take Align?
Healthy people who are interested in promoting their digestive wellness would benefit from taking Align.* Taking Align supplements your digestive system with good bacteria to help your digestive balance and promote digestive health.*



How does Align help maintain digestive health?
Align supplements your digestive system with good bacteria to help build and maintain a healthy digestive system.*

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What is Bifantis?
Bifantis is the trademarked name for a unique, patented strain of beneficial bacteria, Bifidobacterium infantis 35624. Bifantis is the natural probiotic ingredient found only in Align. The specific and pure strain of Bifantis found in Align helps build and maintain a strong, healthy digestive system.* Align is the only probiotic supplement that contains Bifantis.



What is a probiotic?
The word "probiotic" means "for life." Probiotics are good bacteria that provide a health benefit and are essential for many vital body functions, including healthy digestion. Probiotics are increasingly being used and evaluated in the management of digestive health. When you were very young, most of the bacteria in your digestive system were good Bifidobacteria. Your body needs beneficial bacteria like Bifidobacteria for a number of things, including healthy digestion. But they're fragile. Common issues such as diet and stress can disrupt your natural balance of good bacteria. Align contains Bifantis, a probiotic that supplements your digestive system with good Bifidobacteria.*



Is Align a drug or medicine?
No, Align is a daily probiotic dietary supplement—it is not a drug or a medicine.



I've always heard bacteria are bad. Why is taking bacteria good?
When you were very young, most of the bacteria in your digestive system were good Bifidobacteria. Align delivers Bifantis, a unique good Bifidobacteria that helps your digestive balance.* Your body needs beneficial bacteria for a number of things, including healthy digestion. These essential bacteria are sensitive to things such as changes in diet and schedule, stress, and travel. Taking Align once a day, each day, supplements your system with Bifantis bacteria to help promote a healthy digestive system and to support your digestive balance.*



Why does Align have a statement that it has not been reviewed by the FDA?
Align is a dietary supplement. With few exceptions, most dietary supplements that make claims to benefit structures or functions of the human body (such as gastrointestinal health) are required by the FDA to carry this statement, which is called the "Dietary Supplement Health and Education Act (DSHEA) Disclaimer."



Taking Align Questions

What forms does Align come in?
Align comes in a capsule that you take once a day, each day.

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How often do I need to take Align?
We recommend that you take Align once a day, each day.



What happens if I stop taking Align for a few days?
Align is most effective when taken daily. If you miss a day, there's no need to take two Align capsules in one day to make up for the capsule you missed. Just start again the next day to stay on track for healthy digestive balance.*



Can I take two Align capsules daily?
We recommend that you follow the usage instructions and take one capsule daily. You should review the labeling to ensure Align is right for you and consult your healthcare professional if you have severe or chronic digestive problems or if you have questions.



When is the best time of day to take Align?
It doesn´t matter what time of day you take Align. We recommend that you take Align as part of your daily routine, at a time that will be easy to remember—such as when you take your usual vitamins or medications.



Are there any special instructions for how to take Align?
No. You can take Align at any time of the day, with food or without. We recommend that you take Align as part of your daily routine, at a time of day that will be easy to remember—such as when you take your usual vitamins or medications.



What should I do if I forget to take it for a day or two?
Align is most effective when taken daily. If you forget to take your Align capsule every now and then, there's no need to double up on Align capsules when you remember—just take the next capsule at your usual time as part of your routine.

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Can I take it with my vitamins/supplements?
Yes. Align can be taken with vitamins and/or supplements.



Can I take it with my prescription medications?
If you are concerned about taking Align with your medications, you should check with your healthcare provider before using Align.



Can I take Align with antibiotics?
Some antibiotics may make Align less effective. If you are taking an antibiotic, consult your doctor for advice.



Should I stop my digestive medications when I start Align?
No. Align is not intended to replace any of your digestive system medications. Align is a daily probiotic supplement that naturally helps build a strong, healthy digestive system with regular use.* If you are taking digestive medications, you should check with your healthcare provider before using Align to ensure it is right for you.



Are there any restrictions on how to take it?
No. Align is designed to be taken daily as part of your healthy lifestyle. We recommend that you take Align as part of your daily routine, at a time that will be easy to remember.



Can my child take this?
We recommend you keep Align out of the reach of children. If you are unsure if Align is right for your child, consult your child's physician or healthcare professional.

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Where do I store Align? Can I put Align into my pill keeper? Is it OK to store it in the bathroom or kitchen? Can I keep Align in my purse?
To maximize the effectiveness of Align, we recommend that you store Align in its original blister pack. You should store the blister package at or below room temperature (24° C/75° F). We recommend that you do not put Align into other packages, including pill keepers.



Does Align need to be refrigerated?
No, it is not necessary to refrigerate Align.



Why doesn't Align need to be refrigerated?
The Bifantis in Align has been freeze-dried, and does not require refrigeration. Align has been formulated and tested to confirm that it remains effective without refrigeration for a 24-month shelf life. We recommend that Align be kept in the original blister package, as these materials were designed to protect the bacteria from the environment.

Product stability studies show that Align is effective through at least the "best by" date on the bottom flap of the box. Because Align does not need to be refrigerated, it is an ideal product for busy people who want to have the freedom to go where they want and do what they want.



Can I open the capsule and sprinkle the contents into my food or drink?
We designed the Align capsule to be swallowed whole, and for best results we recommend you take the capsule this way if you are able. If you are unable to swallow the capsule, it is OK to open the capsule and sprinkle the contents into a cold drink or food. We recommend that you do not sprinkle the contents into hot foods or beverages, and that you use the product immediately after mixing the contents.



How many bacteria are in each capsule of Align?
Each Align capsule contains at least 1 x 109 colony-forming units (CFU) of live Bifantis bacteria at the time of manufacture. This is the same as 1 billion bacteria.



Is Align like yogurt? How is it different from probiotic yogurts?
Align contains probiotic bacteria, similar to those in the active cultures of yogurt or fermented milk products. However, yogurt in the United States is not required to contain any live cultures, and tests have shown that some yogurt products have a wide range of levels of live bacteria. The delivery of probiotics in either yogurt or fermented milk is limited by the need for cold storage and an associated shorter shelf life. Additionally, many people may have trouble consuming sufficiently large quantities of these products.

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Health/Safety Questions

What are the side effects of Align?
In clinical studies, there was no difference in side effects between Align and placebo (e.g. sugar pill). Side effects, if they occur, tend to be mild and digestive in nature. As with other probiotics, in the first few days of taking Align, some consumers have reported experiencing some gas and bloating. This may be temporary while your system is adjusting to Align.

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Is Align habit forming?
No, Align is not habit forming.



Can I take Align if I am pregnant/breastfeeding/trying to become pregnant?
Although Align has not been formally studied during pregnancy, in breastfeeding women, or in women trying to become pregnant, a review of available probiotic data does not suggest cause for concern. As with any proposed dietary change during pregnancy or breastfeeding, you should consider asking a healthcare professional if Align is right for you during this time.



Is it safe to take Align every day?
Align is designed to be used once a day, every day, as part of your healthy lifestyle.



Can I take Align if I am severely ill or immunocompromised?
Although Align has not been formally studied in people who are severely ill or immunocompromised, a review of available probiotic data does not suggest cause for concern. As with other dietary changes, patients who are severely ill or immunocompromised should be evaluated by their healthcare professional to determine if Align is right for them.



I have lactose intolerance. Can I use Align?
Align is lactose-free and should not cause problems for individuals who are lactose intolerant. However, Align contains milk protein that is added during the manufacturing process and should not be taken by people who have milk allergies.



Is there anybody who should not use Align?
Individuals who have allergies to milk protein should not use Align, as Align contains trace amounts of milk protein.

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The Align label says it contains milk protein. Can you explain?
Milk protein is an ingredient that is added to the product during the culturing process. Federal food regulations require dietary supplement manufacturers to mention on the label if any milk components may be present. If you are allergic to milk protein, you should avoid the use of Align.



Where-to-Buy Questions

Where can I purchase Align?
Align is available for purchase online or in stores nationally. If Align is not available on the shelf, Align can still be ordered through the pharmacy; just ask the pharmacist to order Align for you for in-store pickup. It should be delivered to the pharmacy within a day or two.

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Miscellaneous Questions

My friend's doctor gave her a sample. How can I get a sample?
Align is being sampled to physicians across the country. Ask your doctor if he or she has samples of Align.

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Why are there 28 capsules instead of 30 in a box?
One box of Align contains a four-week supply (28 days) to help you get into the habit of ordering your next box on the same day each month so you never have to be out of Align.



Did the color of the printing on the capsule change? When?
The original Align capsules were printed with the word "Align" in blue. Starting around March 2009, the printing changed to green. In January 2011, we started to remove the printed word "Align" from the capsule. However, capsules with the printed word "Align" will be available in the market for several months. There is no other difference between the two capsules.



How should I store Align? Will cooler temperatures affect the stability of Align? Will warmer temperatures affect the stability of Align?
To maximize the effectiveness of Align, we recommend that you store Align in its original blister pack. You should store the blister package at or below room temperature (24° C/75° F). We recommend that you do not put Align into other packages, including pill keepers.

When kept in the original packaging, cooler temperatures, including freezing, will not affect the stability of Align.

Align is stable at high temperatures for a short period of time (less than three months) when kept in the original packaging.



Ingredients Questions

When did you remove soy protein from Align? How can I tell if my product has soy?
Soy was removed from the Align product that has been available since March 2009 (green box). Soy was present in the Align product that was available in the original yellow and blue box.

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What are the purposes of the ingredients in Align?
Microcrystalline cellulose: For even dispersal of cultures (vegetable origin)
Hypromellose: Vegetarian capsule shell
Sugar: Adds to formulation stability of bacteria
Magnesium stearate: For even dispersal of cultures
Milk protein: For culturing process
Titanium dioxide: To give an opaque appearance
Sodium citrate dihydrate: Adds to formulation stability of bacteria
Propyl gallate: Antioxidant stabilizer added to preserve the Align capsules
FD&C blue #1, riboflavin: Color to make capsules distinctive



Alcohol
Align does not contain this ingredient.



Animal by-products
Align contains milk protein (cow sourced), and is free of other animal by-products. The ingredients used to make the capsules are plant sourced, and do not contain gelatin.



Artificial colors
Color is used to print the word "Align" on the capsule and is present in a very small amount. In January 2011, we started to remove the printed word "Align" from the capsule. However, capsules with the printed word "Align" will be available in the market for several months. There is no other difference between the two capsules.



Aspartame and phenylalanine
Align does not contain artificial flavor or sweeteners.



Calories
Each Align capsule contains a negligible amount of food energy (calories). Align contains 1 calorie per capsule.

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Carbohydrates
Each Align capsule contains less than a gram of carbohydrates.



Citric acid
Align contains a small amount of citric acid.



Corn oil
Align does not contain this ingredient.



Corn products or derivatives
Align does not contain this ingredient.



Dairy or dairy by-products
Align contains caseinate, a milk protein. Align is lactose-free.



Fat
Align is fat-free.

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Fiber
Align does not contain dietary fiber.



Fructose
Align does not contain this ingredient.



Gelatin
Align capsules do not contain gelatin. Align capsule ingredients are vegetable sources.



Gluten
Align does not contain gluten.



Lactose
Align does not contain this ingredient.



Lecithin
Align does not contain this ingredient.

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Maltodextrin
Align does not contain this ingredient.



Modified food starch
Align does not contain this ingredient.



Molasses
Align does not contain this ingredient.



MSG
Align does not contain this ingredient.



Nuts
Align does not contain this ingredient.



Phenolphthalein
Align does not contain this ingredient.

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Phenylalanine
We do not add phenylalanine or aspartame to Align capsules. Align capsules do contain a small amount of protein that naturally contains phenylalanine.



Protein
Align retains a low level of milk protein from the culturing process. Federal food regulations require dietary supplement manufacturers to mention on the label if any milk components may be present. If you are allergic to milk protein, you should avoid the use of Align.



Psyllium
Align does not contain this ingredient.



Saccharin
Align does not contain this ingredient.



Sodium
Align capsules are low in sodium.



Soy
Current Align capsules do not contain soy. Soy was removed from the Align product that has been available since March 2009 (green box). Align capsules that are in the original yellow and blue box do contain soy protein.

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Sucrose
Align capsules do contain a small amount of sucrose. However, Align capsules contain a negligible amount of food energy (calories). Align contains 1 calorie per capsule.



Sugar
Align capsules do contain a small amount of sugar. However, Align capsules contain a negligible amount of food energy (calories). Align contains 1 calorie per capsule.



Sulphites
Align does not contain this ingredient.



Transfatty acids
Align does not contain this ingredient.



Vitamins C, E, and K
Align may contain trace amounts of these ingredients.



Wheat
Align does not contain this ingredient.

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Yeast
Align may contain trace amounts of yeast due to the yeast fermentation process.



* These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

** Among gastroenterologists who recommended a brand of probiotic in a Wolters Kluwer 2010 survey

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