FDA Label for Premier Value Fiber

View Indications, Usage & Precautions

Premier Value Fiber Product Label

The following document was submitted to the FDA by the labeler of this product Chain Drug Consortium, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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Drug Facts


Active Ingredient (In Each Capsule)



Psyllium husk approximately 0.52 g


Purpose



Fiber laxative


Uses



  • •effective in treating occasional constipation and restoring regularity

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

  • •a sudden change in bowel habits persisting for 2 weeks
  • •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

    • •constipation lasts more than 7 days
    • •rectal bleeding occurs
    • These may be signs of a serious condition.


Keep Out Of Reach Of Children



In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.


Directions



  • •take at the first sign of irregularityke this product (child or adult dose) 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.
  • adults 12 years and older: 5 capsules with at least 8 oz. 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
  • children 12 years and under: ask a doctor
  • •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.
  • •As your body adjusts to increased fiber intake, you may experience changes in bowel habits or minor bloating.

Other Information



  • each capsule contains potassium 5 mg
  • •capsules are sealed using a band around the middle
  • •store at room temperature tightly closed to protect from humidity
  • •contains a 100% natural, therapeutic fiber
  • •do not use if printed seal is broken or missing

Inactive Ingredients



caramel color, edible ink, gelatin, polysorbate 80


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 Fiber Laxative
Fiber Laxative/Dietary Supplement

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*


* Please review the disclaimer below.