TOPCO FIBER THERAPY SUGAR FREE- psyllium husk powder

Topco Fiber Therapy by

Drug Labeling and Warnings

Topco Fiber Therapy by is a Otc medication manufactured, distributed, or labeled by TOPCO ASSOCIATES LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

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
• ▪ 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:

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

topcare@topco.com www.topcarebrand.com

INGREDIENTS AND APPEARANCE

TOPCO FIBER THERAPY  SUGAR FREE
psyllium husk powder

Product 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 not final	part334	04/18/2019

Labeler - TOPCO ASSOCIATES LLC (006935977)