Label: PREMIER VALUE FIBER- psyllium husk capsule
- NDC Code(s): 68016-649-00
- Packager: Chain Drug Consortium, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 3, 2023
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each capsule)
- Purpose
- Uses
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Warnings
Choking
Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting, or difficulty in swallowing or breathing after taking this product, seek immediate medical attention.
Allergy alert
This product may cause allergic reaction in people sensitive to inhaled or ingested psyllium.
Ask a doctor before use if you have
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- a sudden change in bowel habits persisting for 2 weeks
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- abdominal pain, nausea or vomiting
Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.
Stop use and ask a doctor if
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- constipation lasts more than 7 days
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- rectal bleeding occurs
These may be signs of a serious condition.
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Directions
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- Take this product with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. See choking warning.
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- Adults 12 years and older: 5 capsules with at least 8 ounces. of liquid (swallow 1 capsule at a time) at the first sign of irregularity. Can be taken up to 3 times a day. Generally produces effect in 12-72 hours
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- children 12 years and under: ask a doctor
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- Laxatives, including bulk fibers, may affect how well other medicines work. If you are taking a prescription medication by mouth, take this product at least 2 hours before or 2 hours after the prescribed medicine.
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- As your body adjusts to increased fiber intake, you may experience changes in bowel habits or minor bloating.
- Other information
- Inactive ingredients
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PRINCIPAL DISPLAY PANEL - 160 Capsules Label
NDC 68016-649-00
COMPARE TO THE ACTIVE INGREDIENT IN METAMUCIL® CAPSULES 3 in 1 MULTIHEALTH FIBER!™*
Premier Value®
Fiber Capsules
100% NATURAL PSYLLIUM HUSK
FIBER LAXATIVE/DIETARY SUPPLEMENT- •
- Helps maintain healthy blood sugar levels as part of your diet**
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- Helps lower cholesterol to promote heart health
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- Promotes digestive health**
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- Gluten free
160 CAPSULES
Distributed by
Chain Drug Consortium, LLC.
3301 N.W. Boca Raton Blvd.,
Suite 101, Boca Raton FL 33431
*This product is not manufactured or distributed by Procter & Gamble, the distributor of Metamucil Capsules 3 in 1 MultiHealth Fiber!™*
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INGREDIENTS AND APPEARANCE
PREMIER VALUE FIBER
psyllium husk capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-649 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Psyllium Husk (UNII: 0SHO53407G) (Psyllium Husk - UNII:0SHO53407G) Psyllium Husk 0.52 g Inactive Ingredients Ingredient Name Strength CARAMEL (UNII: T9D99G2B1R) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) POLYSORBATE 80 (UNII: 6OZP39ZG8H) Product Characteristics Color BROWN Score no score Shape CAPSULE Size 21mm Flavor Imprint Code FC119 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68016-649-00 100 in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M007 07/01/2011 Labeler - Chain Drug Consortium, LLC (101668460)