TOPCO FIBER THERAPY SUGAR FREE- psyllium husk powder

United States - English - NLM (National Library of Medicine)

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Active ingredient:
PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G)
Available from:
TOPCO ASSOCIATES LLC
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Bulk-forming Laxative
Authorization status:
OTC monograph not final
Authorization number:
36800-558-80

TOPCO FIBER THERAPY SUGAR FREE- psyllium husk powder

TOPCO ASSOCIATES LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

TopCare

health

PSYLLIUM HUSK Orange Flavor Sugar free 180 Teaspoon Doses

Drug Facts

Active ingredient: (in each TEASPOON)

Psyllium husk approximately 3.4 g

Purpos e

Bulk-forming Laxative

Us es :

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

Stop use and ask a doctor if

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 :

®

for relief of occasional constipation (irregularity)

generally produces bowel movement in 12-72 hours

a sudden change in bowel habits persisting for 2 weeks

abdominal pain, nausea or vomiting

constipation lasts more than 7 days

rectal bleeding occurs

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:

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

ORANGE FLAVOR

NATURALLY AND ARTIFICIALLY FLAVORED

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

®

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

180 TEASPOON Doses

FILL CONTROLLED BY WEIGHT, NOT VOLUME

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

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

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

TOPCO ASSOCIATES LLC

TOPCO FIBER THERAPY SUGAR FREE

psyllium husk powder

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:36 8 0 0 -558

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PSYLLIUM HUSK (UNII: 0 SHO5340 7G) (PSYLLIUM HUSK - UNII:0 SHO5340 7G)

PSYLLIUM HUSK

3.4 g in 5.79 g

Inactive Ingredients

Ingredient Name

Stre ng th

ASPARTAME (UNII: Z0 H242BBR1)

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

FD&C Yello w No . 6 (UNII: H77VEI9 3A8 )

MALTO DEXTRIN (UNII: 7CVR7L4A2D)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

Product Characteristics

Color

BROWN (Light Yello wish)

S core

S hap e

S iz e

Flavor

ORANGE (natural and artifcial)

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date Marketing End Date

1

NDC:36 8 0 0 -558 -

10 40 g in 1 CANISTER; Type 0 : No t a Co mbinatio n Pro duct

0 4/18 /20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt334

0 4/18 /20 19

Labeler -

T OPCO ASSOCIAT ES LLC (006935977)

Revised: 5/2019

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