Topcare ®

Topcare ®
SPL v7
SPL
SPL Set ID 2c61e73e-b3f7-4ab2-8bda-e65a2c0b3560
Route
ORAL
Published
Effective Date 2019-05-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Psyllium Husk (3.4 g)
Inactive Ingredients
Aspartame Anhydrous Citric Acid Fd&c Yellow No. 6 Maltodextrin Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Color: brown
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-04-18
Description

Drug Facts

Purpose

Bulk-forming Laxative

Medication Information

Purpose

Bulk-forming Laxative

Description

Drug Facts

Uses:
  • for relief of occasional constipation (irregularity)
  • generally produces bowel movement in 12-72 hours
Section 42229-5

Drug Facts

Section 50565-1

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.

Section 50566-9

Stop use and ask a doctor if

  • constipation lasts more than 7 days
  • rectal bleeding occurs

These may be signs of a serious condition.

Section 50569-3

Ask a doctor before use if you have

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

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.

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.

Allergy Alert:

This product may cause allergic reaction in people sensitive to inhaled or ingested psyllium.

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 cholesterolto promote heart health†
  • Promotes digestive health**
  • Helps maintain healthy blood sugarlevels 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

Active Ingredient: (in Each Teaspoon)

Psyllium husk approximately 3.4 g

Structured Label Content

Uses:
  • for relief of occasional constipation (irregularity)
  • generally produces bowel movement in 12-72 hours
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • constipation lasts more than 7 days
  • rectal bleeding occurs

These may be signs of a serious condition.

Section 50569-3 (50569-3)

Ask a doctor before use if you have

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

Bulk-forming Laxative

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.

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.

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.

Allergy Alert: (Allergy alert:)

This product may cause allergic reaction in people sensitive to inhaled or ingested psyllium.

Other Information: (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: (Inactive ingredients:)

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

Questions Or Comments? (Questions or comments?)

1-888-423-0139

Principal Display Panel (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 cholesterolto promote heart health†
  • Promotes digestive health**
  • Helps maintain healthy blood sugarlevels 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

Active Ingredient: (in Each Teaspoon) (Active ingredient: (in each TEASPOON))

Psyllium husk approximately 3.4 g

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:15.002817 · Updated: 2026-03-14T23:13:32.363247