Topco Fiber Therapy Powder
FDA Label NDC 36800-558

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Topco Fiber Therapy (NDC 36800-558). 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 teaspoon), purpose, uses:, choking:, allergy alert:, otc - ask doctor, otc - stop use, 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 Teaspoon)

Psyllium husk approximately 3.4 g

Purpose

Bulk-forming Laxative

Uses:

  • ▪for relief of occasional constipation (irregularity)
  • ▪generally produces bowel movement in 12-72 hours

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.

Otc - Ask Doctor

Ask a doctor before use if you have

  • ▪a sudden change in bowel habits persisting for 2 weeks
  • ▪abdominal pain, nausea or vomiting

Otc - Stop Use

Stop use and ask a doctor if

  • ▪constipation lasts more than 7 days
  • ▪rectal bleeding occurs

    • These may be signs of a serious condition.

Otc - Keep Out Of Reach Of Children

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:

Put one dose into an empty glass. Mix 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. Stir briskly and drink promptly. If mixture thickens, add more liquid and stir.

Adults & children 12 years & older:

1 rounded teaspoon in 8 oz. of liquid at the first sign of irregularity. Can be taken up to 3 times daily.

Children 6-11 yrs :

½ adult dose in 8 oz. of liquid, up to 3 times daily

Children under 6 yrs:

Consult a doctor

Bulk-forming fibers like psyllium husk may affect how well other medicines work. If you are taking a prescription medicine by mouth, take this product at least 2 hours before or 2 hours after the prescribed medicine.

New Users:

Start with 1 serving per day; gradually increase to 3 doses per day as necessary. You may initially experience changes in bowel habits or minor bloating, as your body adjusts to increased fiber intake.

Other Information:

  • ▪each teaspoon contains: potassium 35 mg; sodium 5 mg
  • ▪PHENYLKETONURICS: CONTAINS PHENYLALANINE, 25 mg per teaspoon
  • ▪contains a therapeutic fiber
  • ▪store at room temperature. Keep the container tightly closed to protect from humidity

Inactive Ingredients:

aspartame, citric acid, FD&C Yellow 6, maltodextrin, natural and artificial orange flavor, silica.

Questions Or Comments?

1-888-423-0139

Principal Display Panel

NDC 36800-558-80

COMPARE TO THE METAMUCIL® 4 IN 1 MULTIHEALTH FIBER! ™*

SUGAR FREE (NOT A LOW CALORIE FOOD)

Fiber Therapy

PSYLLIUM HUSK DAILY FIBER SUPPLEMENT THERAPY FOR REGULARITY

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

    • ORANGE FLAVOR

    NATURALLY AND ARTIFICIALLY FLAVORED

    180 TEASPOON‡ Doses

    FILL CONTROLLED BY WEIGHT, NOT VOLUME

    NET WT 36.8 OZ (2 LB 4.8 OZ) 1.04 kg

    K

    PAREVE

    QUALITY GURANTEED

    ‡Serving size varies See DIRECTIONS on back panel for more information

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

    **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.

    TAMPER EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS BROKEN OR MISSING

    *This product is not manufactured or distributed by Procter & Gamble, the distributor of Metamucil® 4 in 1 MultiHealth Fiber!™.

    This product has a low glycemic index, a measure of the effect of dietary carbohydrates on blood sugar levels.

    This Top Care product is laboratory tested to guarantee its highest quality. You total satisfaction is guaranteed.

    DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007

    © TOPCO RARA1217

    QUESTIONS? 1-888-423-0139

    [email protected] www.topcarebrand.com

    Topcare Health Sugar Free Fiber Therapy Psyllium Husk (51572pvlr)

    Topcare Health Sugar Free Fiber Therapy Psyllium Husk (51572pvlr)

* Please review the disclaimer below.