Premier Value Fiber Capsule
FDA Label NDC 68016-649

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Consortium, Llc for the product Premier Value Fiber (NDC 68016-649). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient (in each capsule), purpose, uses, choking, allergy alert, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

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*

Premier Value Fiber Capsules (119160pvlr Ol)

Premier Value Fiber Capsules (119160pvlr Ol)

* Please review the disclaimer below.