Stomach Relief

Stomach Relief
SPL v4
SPL
SPL Set ID 73d0ad99-9fe9-4258-9e3b-421ef173ae2f
Route
ORAL
Published
Effective Date 2022-11-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (262 mg)
Inactive Ingredients
Synthetic Beeswax Silicon D&c Red No. 33 Fd&c Yellow No. 6 Gelatin Glycerin Paraffin Water Lecithin, Soybean Hydroxymethyl Cellulose Sorbitol Solution Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 262 Shape: capsule Color: pink Size: 14 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-11-17

Description

Bismuth subsalicylate 262 mg

Purpose

Upset stomach reliever and anti-diarrheal


Medication Information

Purpose

Upset stomach reliever and anti-diarrheal

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

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 (1 dose) every 1/2 hour or 4 softgels (2 doses) every hour as needed for diarrhea • 2 soft gels (1 dose) every 1/2 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

Drug Facts

Other Information

• each softgel contains: Salicylate 99 mg • very low sodium • store between 15–30°C (59–86°F)

Inactive Ingredients

Aerosil, beeswax, FD&C Red No. 33, FD&C Yellow No. 6, gelatin, glycerin, light liquid paraffin, purified water, soya lecithin, sodium carboxy methyl cellulose, sorbitol solution, titanium dioxide

Do Not Use If You Have

• an ulcer • a bleeding problem • bloody or black stool

Questions Or Comments?

1-888-333-9792

Principal Display Panel

When Using This Product

• symptoms get worse or last more than 2 days • 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 right away. (1-800-222-1222)

Active Ingredient (in Each Tablet)

Bismuth subsalicylate 262 mg

Ask A Doctor Before Use If You Have

• fever • mucus in the stool

Ask A Doctor Or Pharmacist Before Use If You Are If You Are

you are taking any drug for • anticoagulation (thinning the blood) • diabetes • gout • arthritis


Structured Label Content

Uses

relieves • travelers’ diarrhea • diarrhea • upset stomach due to overindulgence in food and drink, including: • heartburn • indigestion • nausea • gas • belching • fullness

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

• swallow with water, do not chew • adults and children 12 years and over: • 2 softgels (1 dose) every 1/2 hour or 4 softgels (2 doses) every hour as needed for diarrhea • 2 soft gels (1 dose) every 1/2 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

Drug Facts

Other Information (Other information)

• each softgel contains: Salicylate 99 mg • very low sodium • store between 15–30°C (59–86°F)

Inactive Ingredients (Inactive ingredients)

Aerosil, beeswax, FD&C Red No. 33, FD&C Yellow No. 6, gelatin, glycerin, light liquid paraffin, purified water, soya lecithin, sodium carboxy methyl cellulose, sorbitol solution, titanium dioxide

Do Not Use If You Have (Do not use if you have)

• an ulcer • a bleeding problem • bloody or black stool

Questions Or Comments? (Questions or comments?)

1-888-333-9792

Principal Display Panel

When Using This Product (When using this product)

• symptoms get worse or last more than 2 days • 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 right away. (1-800-222-1222)

Active Ingredient (in Each Tablet) (Active Ingredient (in each tablet))

Bismuth subsalicylate 262 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 If You Are (Ask a doctor or pharmacist before use if you are if you are)

you are taking any drug for • anticoagulation (thinning the blood) • diabetes • gout • arthritis


Advanced Ingredient Data


Raw Label Data

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