Foster And Thrive Regular Strength Stomach Relief -527

SPL v2

SPL

SPL Set ID f204f9ab-645b-4656-93a1-90aa4c369922

Route

ORAL

Published

Effective Date 2024-12-12

Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients

Bismuth Cation (525 mg)

Inactive Ingredients

Benzoic Acid D&c Red No. 22 D&c Red No. 28 Potassium Hydroxide Water Saccharin Sodium Salicylic Acid Hydroxyethyl Cellulose (1500 Mpa.s At 1%) Dimethicone Xanthan Gum

Identifiers & Packaging

Pill Appearance

Color: pink

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-08-02

Description

Bismuth subsalicylate 525 mg

Purpose

Upset stomach reliever and anti-diarrheal

Medication Information

Purpose

Upset stomach reliever and anti-diarrheal

Description

Bismuth subsalicylate 525 mg

Uses

relieves:

diarrhea
heartburn
indigestion
nausea
upset stomach associated with these symptoms

Warnings

Reye's Syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's Syndrome, a rare but serious illness.

Allergy alert: Contains salicylate. Do not take if you are

allergic to salicylates (including aspirin)
taking other salicylate products

Directions

shake well before use
mL = milliliter
TBSP = tablespoon
adults and children 12 years and over: 1 dose (2 TBSP or 30 mL) every 1/2 to 1 hour as needed
do not exceed 8 doses (16 TBSP or 240 mL) in 24 hours
use until diarrhea stops but not more than 2 days
children under 12 years: ask a doctor
drink plenty of clear fluids to help prevent dehydration caused by diarrhea

Other Information

each 30 mL or 2 TBSP contains:
potassium 25 mg
salicylate 260 mg
sodium 8 mg
protect from freezing
avoid excessive heat (over 104^oF or 40^oC).
dosage cup provided

Inactive Ingredients

benzoic acid, D&C red # 22, D&C red #28, flavor, hydroxyethyl cellulose, potassium hydroxide, purified water, saccharin sodium, salicylic acid, simethicone, xanthan gum.

Do Not Use If You Have

an ulcer
bloody or black stool
a bleeding problem

Questions Or Comments?

Call 833-358-6431 Monday to Friday 9:00 am to 7:00 pm EST

Principal Display Panel

NDC 70677-1191-1

COMPARE TO PEPTO-BIMOL^® ACTIVE INGREDIENT*

Foster and Thrive ^TM

REGULAR STRENGTH

Stomach Relief

Bismuth Subsalicylate 525mg

ANTIDIARRHEAL UPSET STOMACH RELIEVER

Relieves:

Upset Stomach
Nausea
Heartburn
Indigestion
Diarrhea

8 FL. OZ. (236 mL)

When Using This Product

a temporary, but harmless darkening of the stool and/or tongue may occur

Stop Use and Ask Doctor If

symptoms get worse
ringing in the ears or loss of hearing occurs
diarrhea lasts more than 2 days

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center immediately(1-800-222-1222).

Active Ingredient(in Each 30 Ml)

Bismuth subsalicylate 525 mg

Ask A Doctor Before Use If You Have

fever
mucus in the stool

Ask A Doctor Or Pharmacist Before Use If You Are

taking any drug for

anticoagulation (thinning of the blood)
diabetes
gout
arthritis

Structured Label Content

Uses (USES)

relieves:

diarrhea
heartburn
indigestion
nausea
upset stomach associated with these symptoms

Purpose (PURPOSE)

Upset stomach reliever and anti-diarrheal

Warnings (WARNINGS)

allergic to salicylates (including aspirin)
taking other salicylate products

Directions (DIRECTIONS)

shake well before use
mL = milliliter
TBSP = tablespoon
adults and children 12 years and over: 1 dose (2 TBSP or 30 mL) every 1/2 to 1 hour as needed
do not exceed 8 doses (16 TBSP or 240 mL) in 24 hours
use until diarrhea stops but not more than 2 days
children under 12 years: ask a doctor
drink plenty of clear fluids to help prevent dehydration caused by diarrhea

Other Information (OTHER INFORMATION)

each 30 mL or 2 TBSP contains:
potassium 25 mg
salicylate 260 mg
sodium 8 mg
protect from freezing
avoid excessive heat (over 104^oF or 40^oC).
dosage cup provided

Inactive Ingredients (INACTIVE INGREDIENTS)

benzoic acid, D&C red # 22, D&C red #28, flavor, hydroxyethyl cellulose, potassium hydroxide, purified water, saccharin sodium, salicylic acid, simethicone, xanthan gum.

Do Not Use If You Have (DO NOT USE IF YOU HAVE)

an ulcer
bloody or black stool
a bleeding problem

Questions Or Comments? (QUESTIONS OR COMMENTS?)

Call 833-358-6431 Monday to Friday 9:00 am to 7:00 pm EST

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 70677-1191-1

COMPARE TO PEPTO-BIMOL^® ACTIVE INGREDIENT*

Foster and Thrive ^TM

REGULAR STRENGTH

Stomach Relief

Bismuth Subsalicylate 525mg

ANTIDIARRHEAL UPSET STOMACH RELIEVER

Relieves:

Upset Stomach
Nausea
Heartburn
Indigestion
Diarrhea

8 FL. OZ. (236 mL)

When Using This Product (WHEN USING THIS PRODUCT)

a temporary, but harmless darkening of the stool and/or tongue may occur

Stop Use and Ask Doctor If (STOP USE AND ASK DOCTOR IF)

symptoms get worse
ringing in the ears or loss of hearing occurs
diarrhea lasts more than 2 days

If Pregnant Or Breast Feeding, (IF PREGNANT OR BREAST-FEEDING,)

ask a health professional before use.

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 immediately(1-800-222-1222).

Active Ingredient(in Each 30 Ml) (ACTIVE INGREDIENT(in each 30 mL))

Bismuth subsalicylate 525 mg

Ask A Doctor Before Use If You Have (ASK A DOCTOR BEFORE USE IF YOU HAVE)

fever
mucus in the stool

Ask A Doctor Or Pharmacist Before Use If You Are (ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE)

taking any drug for

anticoagulation (thinning of the blood)
diabetes
gout
arthritis

Advanced Ingredient Data

[{"name": "BISMUTH CATION", "unii": "ZS9CD1I8YE", "classCode": "ACTIB", "strengthNumerator": "525", "strengthDenominator": "30", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "BENZOIC ACID", "unii": "8SKN0B0MIM", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 22", "unii": "1678RKX8RT", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 28", "unii": "767IP0Y5NH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POTASSIUM HYDROXIDE", "unii": "WZH3C48M4T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SALICYLIC ACID", "unii": "O414PZ4LPZ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%)", "unii": "L605B5892V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"USES": "relieves: diarrhea heartburn indigestion nausea upset stomach associated with these symptoms", "PURPOSE": "Upset stomach reliever and anti-diarrheal", "WARNINGS": "Reye's Syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's Syndrome, a rare but serious illness. Allergy alert: Contains salicylate. Do not take if you are allergic to salicylates (including aspirin) taking other salicylate products", "DIRECTIONS": "shake well before use mL = milliliter TBSP = tablespoon adults and children 12 years and over: 1 dose (2 TBSP or 30 mL) every 1/2 to 1 hour as needed do not exceed 8 doses (16 TBSP or 240 mL) in 24 hours use until diarrhea stops but not more than 2 days children under 12 years: ask a doctor drink plenty of clear fluids to help prevent dehydration caused by diarrhea", "OTHER INFORMATION": "each 30 mL or 2 TBSP contains: potassium 25 mg salicylate 260 mg sodium 8 mg protect from freezing avoid excessive heat (over 104 o F or 40 o C). dosage cup provided", "INACTIVE INGREDIENTS": "benzoic acid, D&C red # 22, D&C red #28, flavor, hydroxyethyl cellulose, potassium hydroxide, purified water, saccharin sodium, salicylic acid, simethicone, xanthan gum.", "DO NOT USE IF YOU HAVE": "an ulcer bloody or black stool a bleeding problem", "QUESTIONS OR COMMENTS?": "Call 833-358-6431 Monday to Friday 9:00 am to 7:00 pm EST", "PRINCIPAL DISPLAY PANEL": "NDC 70677-1191-1 COMPARE TO PEPTO-BIMOL ® ACTIVE INGREDIENT* Foster and Thrive TM REGULAR STRENGTH Stomach Relief Bismuth Subsalicylate 525mg ANTIDIARRHEAL UPSET STOMACH RELIEVER Relieves: Upset Stomach Nausea Heartburn Indigestion Diarrhea 8 FL. OZ. (236 mL)", "WHEN USING THIS PRODUCT": "a temporary, but harmless darkening of the stool and/or tongue may occur", "STOP USE AND ASK DOCTOR IF": "symptoms get worse ringing in the ears or loss of hearing occurs diarrhea lasts more than 2 days", "IF PREGNANT OR BREAST-FEEDING,": "ask a health professional before use.", "KEEP OUT OF REACH OF CHILDREN.": "In case of overdose, get medical help or contact a Poison Control Center immediately(1-800-222-1222).", "ACTIVE INGREDIENT(in each 30 mL)": "Bismuth subsalicylate 525 mg", "ASK A DOCTOR BEFORE USE IF YOU HAVE": "fever mucus in the stool", "ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE": "taking any drug for anticoagulation (thinning of the blood) diabetes gout arthritis"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:49.916349 · Updated: 2026-03-14T23:05:53.122655