Gencare-upset Stomach Relief-bismuth Subsalicylate 262 Mg

Gencare-upset Stomach Relief-bismuth Subsalicylate 262 Mg
SPL v1
SPL
SPL Set ID 07e2cc82-ab0e-46c5-863b-67658b612678
Route
ORAL
Published
Effective Date 2025-06-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (262 mg)
Inactive Ingredients
Polyethylene Glycol 400 Polysorbate 80 Soybean Lecithin Povidone K30 Gelatin Glycerin Sorbitol Solution Sorbitan D&c Red No. 33 Titanium Dioxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-27

Description

Bismuth subsalicylate 262 mg

Purpose

Upset stomach reliever and antidiarrheal


Medication Information

Purpose

Upset stomach reliever and antidiarrheal

Description

Bismuth subsalicylate 262 mg

Uses

relieves:

■ travelers' diarrhea ■ diarrhea  ■ upset stomach due to overindulgence in food and drink, including  ■ heartburn ■ indigestion ■ nausea ■ gas ■ belching ■ fullness

Section 50565-1

KEEP OUT OF REACH OF CHILDREN In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9

Stop use and ask a doctor if ■ symptoms get worse or last more than 2 days ■ ringing in the ears or loss of hearing occurs ■ diarrhea lasts more than 2 days

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 the blood) ■ diabetes ■ gout ■ arthritis

Section 50569-3

Ask a doctor before use if you have ■ fever ■ mucus in the stool

Section 50570-1

Do not use if you have ■ an ulcer ■ a bleeding problem ■ bloody or black stool

Section 51945-4

Section 53414-9

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

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

■ swallow with water, do not chew

■ adults and children 12 years and over:

■ 2 softgels every ½ hour or 4 softgels every hour as needed for diarrhea

■ 2 softgels every ½ hour to 1 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)

■ do not exceed 8 doses (16 softgels) 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 softgel contains:

■ salicylate 99 mg

■ low sodium

■ do not exceed 25°C

Inactive Ingredients

Polyethylene Glycol-400, Polysorbate 80, Soya Lecithin, Povidone (PVPK 30), Gelatin, Glycerin, Sorbitol Sorbitan Solution, D & C Red 33 , Titanium Dioxide, Purified Water

Questions Or Comments?

Call +1 (732) 994-2808 or email [email protected]

Active Ingredient (in Each Softgel)

Bismuth subsalicylate 262 mg


Structured Label Content

Uses

relieves:

■ travelers' diarrhea ■ diarrhea  ■ upset stomach due to overindulgence in food and drink, including  ■ heartburn ■ indigestion ■ nausea ■ gas ■ belching ■ fullness

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if ■ symptoms get worse or last more than 2 days ■ ringing in the ears or loss of hearing occurs ■ diarrhea lasts more than 2 days

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 the blood) ■ diabetes ■ gout ■ arthritis

Section 50569-3 (50569-3)

Ask a doctor before use if you have ■ fever ■ mucus in the stool

Section 50570-1 (50570-1)

Do not use if you have ■ an ulcer ■ a bleeding problem ■ bloody or black stool

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Purpose

Upset stomach reliever and antidiarrheal

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

■ swallow with water, do not chew

■ adults and children 12 years and over:

■ 2 softgels every ½ hour or 4 softgels every hour as needed for diarrhea

■ 2 softgels every ½ hour to 1 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)

■ do not exceed 8 doses (16 softgels) 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 softgel contains:

■ salicylate 99 mg

■ low sodium

■ do not exceed 25°C

Inactive Ingredients (Inactive ingredients)

Polyethylene Glycol-400, Polysorbate 80, Soya Lecithin, Povidone (PVPK 30), Gelatin, Glycerin, Sorbitol Sorbitan Solution, D & C Red 33 , Titanium Dioxide, Purified Water

Questions Or Comments? (Questions or Comments?)

Call +1 (732) 994-2808 or email [email protected]

Active Ingredient (in Each Softgel) (Active Ingredient (in each softgel))

Bismuth subsalicylate 262 mg


Advanced Ingredient Data


Raw Label Data

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