Stomach Relief

Stomach Relief
SPL v1
SPL
SPL Set ID fbabc313-600a-4722-9948-1a3e21414059
Route
ORAL
Published
Effective Date 2025-09-10
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (525 mg)
Inactive Ingredients
Benzoic Acid D&c Red No. 22 D&c Red No. 28 Water Saccharin Sodium Salicylic Acid Sodium Salicylate Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: pink
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-01

Description

ACTIVE INGREDIENT (in each 30 mL dose cup or 2 tablespoons) Bismuth subsalicylate 525 mg

Purpose

Upset stomach reliever and antidiarrheal


Medication Information

Warnings and Precautions

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

Indications and Usage

Uses relieves • travelers' diarrhea • diarrhea

• upset stomach due to overindulgence of food and drink

including: • heart burn • indigestion • nausea • gas

• belching

Purpose

Upset stomach reliever and antidiarrheal

Dosage and Administration

Directions • Shake well before use

• use dose cup or tablespoon (TBSP)

• adults and children 12 years and over: 1 dose (30 mL or 2

   TBSP) every 1/2 to 1 hour as needed

• do not exceed 8 doses (240 mL or 16 TBSP) 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

Description

ACTIVE INGREDIENT (in each 30 mL dose cup or 2 tablespoons) Bismuth subsalicylate 525 mg

Section 50565-1

Keep out of reach of children. In case of overdose, get

medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if

• diarrhea lasts more than 2 days

• symptoms get worse or last more than 2 days

• ringing in the ears or loss of hearing occurs

Section 50567-7

When using this product a temporary, but harmless,

darkening of the stool and/or tongue may occur

Section 50568-5

Ask a doctor or pharmacist before use if you are

taking any drug for • anticoagulation (thinning of the blood)

• diabetes • gout • arthritis

Section 50569-3

Ask a doctor before use if you have

• fever • mucus in stool

Section 50570-1

Do not use if you have   • an ulcer

• a bleeding problem        • black or bloody stool

Section 51727-6

Inactive ingredients benzoic acid, D&C red #22,

D&C red # 28, flavor, purified water, saccharin sodium,

salicylic acid, sodium salicylate, xanthan gum

Section 53414-9

If pregnant or breast feeding, ask health professional before use.

Section 55106-9

ACTIVE INGREDIENT (in each 30 mL dose cup or 2 tablespoons)

Bismuth subsalicylate 525 mg

Section 60561-8

Other information

• each 30 mL dose cup contains: sodium 13 mg, salicylate 256 mg

• protect from freezing • avoid excessive heat (over 104°F or 40°C)

• low sodium

Purposes

Upset stomach reliever and antidiarrheal

===============================

caring mill™ Stomach Relief Labeling

NDC 81522-557-28

caring mill™

Stomach 

Relief

Compare to the active ingredients in Pepto-Bismol​™

Regular Strength

Bismuth Subsalicylate

Antidiarrheal / Upset Stomach Reliever

12 FL OZ 

(354 mL)

"This product is not manufactured or distributed by

Procter & Gamble, Inc., the distributor of

Pepto-Bismol​™​.

Made in USA     LR-224

Manufactured for FSA Store Inc.

5473 Blair Rd Suite 100

PMB 24308 Dallas, TX 75231

res


Structured Label Content

Indications and Usage (34067-9)

Uses relieves • travelers' diarrhea • diarrhea

• upset stomach due to overindulgence of food and drink

including: • heart burn • indigestion • nausea • gas

• belching

Dosage and Administration (34068-7)

Directions • Shake well before use

• use dose cup or tablespoon (TBSP)

• adults and children 12 years and over: 1 dose (30 mL or 2

   TBSP) every 1/2 to 1 hour as needed

• do not exceed 8 doses (240 mL or 16 TBSP) 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

Warnings and Precautions (34071-1)

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

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.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

• diarrhea lasts more than 2 days

• symptoms get worse or last more than 2 days

• ringing in the ears or loss of hearing occurs

Section 50567-7 (50567-7)

When using this product a temporary, but harmless,

darkening of the stool and/or tongue may occur

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

taking any drug for • anticoagulation (thinning of the blood)

• diabetes • gout • arthritis

Section 50569-3 (50569-3)

Ask a doctor before use if you have

• fever • mucus in stool

Section 50570-1 (50570-1)

Do not use if you have   • an ulcer

• a bleeding problem        • black or bloody stool

Section 51727-6 (51727-6)

Inactive ingredients benzoic acid, D&C red #22,

D&C red # 28, flavor, purified water, saccharin sodium,

salicylic acid, sodium salicylate, xanthan gum

Section 53414-9 (53414-9)

If pregnant or breast feeding, ask health professional before use.

Section 55106-9 (55106-9)

ACTIVE INGREDIENT (in each 30 mL dose cup or 2 tablespoons)

Bismuth subsalicylate 525 mg

Section 60561-8 (60561-8)

Other information

• each 30 mL dose cup contains: sodium 13 mg, salicylate 256 mg

• protect from freezing • avoid excessive heat (over 104°F or 40°C)

• low sodium

Purposes (PURPOSES)

Upset stomach reliever and antidiarrheal

===============================

caring mill™ Stomach Relief Labeling

NDC 81522-557-28

caring mill™

Stomach 

Relief

Compare to the active ingredients in Pepto-Bismol​™

Regular Strength

Bismuth Subsalicylate

Antidiarrheal / Upset Stomach Reliever

12 FL OZ 

(354 mL)

"This product is not manufactured or distributed by

Procter & Gamble, Inc., the distributor of

Pepto-Bismol​™​.

Made in USA     LR-224

Manufactured for FSA Store Inc.

5473 Blair Rd Suite 100

PMB 24308 Dallas, TX 75231

res


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