Label: TOPCO FIBER THERAPY SUGAR FREE- psyllium husk powder
- NDC Code(s): 36800-558-80
- Packager: TOPCO ASSOCIATES LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 20, 2023
If you are a consumer or patient please visit this version.
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- SPL UNCLASSIFIED SECTION
- Active ingredient: (in each TEASPOON)
- 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
- ▪
- a sudden change in bowel habits persisting for 2 weeks
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- abdominal pain, nausea or vomiting
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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.
- Other information:
- Inactive ingredients:
-
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†
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- Promotes digestive health**
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- 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
topcare@topco.com www.topcarebrand.com
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INGREDIENTS AND APPEARANCE
TOPCO FIBER THERAPY SUGAR FREE
psyllium husk powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-558 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G) PSYLLIUM HUSK 3.4 g in 5.79 g Inactive Ingredients Ingredient Name Strength ASPARTAME (UNII: Z0H242BBR1) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C Yellow No. 6 (UNII: H77VEI93A8) MALTODEXTRIN (UNII: 7CVR7L4A2D) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color BROWN (Light Yellowish) Score Shape Size Flavor ORANGE (natural and artifcial) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-558-80 1040 g in 1 CANISTER; Type 0: Not a Combination Product 04/18/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M007 04/18/2019 Labeler - TOPCO ASSOCIATES LLC (006935977)
