Publix Capsule
FDA Label NDC 41415-119

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Publix Super Markets, Inc for the product Publix (NDC 41415-119). 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

    • 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 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.
  • ▪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 daily. 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. Keep the container tightly closed to protect from humidity
  • ▪contains a 100% natural, therapeutic fiber
  • ▪tamper evident: do not use if printed inner seal under cap is broken or missing

Inactive Ingredients

caramel color, edible ink, gelatin, polysorbate 80

Questions Or Comments?

1-866-467-2748

Principal Display Panel - 160 Capsules Label

NDC 41415-119-60

Compare to the active ingredient in Metamucil® 3 in 1 MultiHealth Fiber!™

FIBER CAPSULES

PSYLLIUM HUSK FIBER LAXATIVE

DIETARY SUPPLEMENT

  • Helps maintain blood sugar levels as part of your diet**
  • Helps lower cholesterol to promote heart health††
  • Promotes digestive health**
  • Gluten free

    • 160 CAPSULES

    OUR PHARMACISTS RECOMMEND

    ††See back for information about soluble fiber and heart disease

    **THESE STAEMENTS HAVE NOT BEEN EVALUATED BY FOOD AND DRUG ADMINSTRATION, THIS PRODUCT IS NOT INTEDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE

    GLUTEN FREE (may contain trace amount less than 20 ppm). If you have specific dietary needs, you should dietary needs; you should consult your doctor before consuming this product)

    DISTRIBUTED BY PUBLIX SUPER MARKET, INC.,

    3300 PUBLIX CORPORATE PARKWAY, LAKELAND, FL 33811

    1-888-267-3037 publix.com

    PUBLIX GUARANTEE: COMPLETE SATISFACTION OR YOUR MONEY BACK.

    *This product is not manufactured or distributed by Procter & Gamble, the distributor of Metamucil® 3 in1 MultiHealth Fiber!™.

    Publix 160 Counts Fiber Capsules Psyllium Husk (119160pvlr Ol)

    Publix 160 Counts Fiber Capsules Psyllium Husk (119160pvlr Ol)

* Please review the disclaimer below.