Stomach Relief - Regular Strength 525 mg/30mL

BISMUTH SUBSALICYLATE · LIQUID · AptaPharma Inc.

No Recall History

Plain English

Stomach Relief - Regular Strength is a liquid containing bismuth subsalicylate at 525 mg/30mL, taken oral. Manufactured by AptaPharma Inc..

Key Facts

Brand Name: Stomach Relief - Regular Strength
Generic Name: BISMUTH SUBSALICYLATE
NDC Code (Product): 76281-537
Manufacturer: AptaPharma Inc.
Strength: 525 mg/30mL
Dosage Form: LIQUID
Route: ORAL
Marketing Status
Application #: M008
Drug Class: Bismuth [EPC]
Marketing Start: 10/01/2018

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

nausea90 reports

vomiting72 reports

diarrhoea70 reports

abdominal pain56 reports

drug ineffective56 reports

pain54 reports

constipation43 reports

abdominal distension39 reports

off label use37 reports

abdominal pain upper34 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

Directions shake well before use only use dose cup provided adults and children 12 years and over: 15 mL (1 dose) every ½ hour or 30 mL (2 doses) every hour as needed for diarrhea/traveler’s diarrhea 15 mL (1 dose) every ½ hour as needed overindulgence (upset stomach, heartburn, indigestion, nausea) do not exceed 8 doses (120 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

Warnings

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 or 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 Do not use if you have an ulcer a bleeding problem bloody or black stool 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 the blood) diabetes gout arthritis When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur 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 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).

Frequently Asked Questions

What is Stomach Relief - Regular Strength used for?

Stomach Relief - Regular Strength contains BISMUTH SUBSALICYLATE. It is a liquid taken oral. Consult your doctor for specific uses.

Is Stomach Relief - Regular Strength a controlled substance?

Stomach Relief - Regular Strength is not classified as a controlled substance by the DEA.

What is the generic name for Stomach Relief - Regular Strength?

The generic name for Stomach Relief - Regular Strength is BISMUTH SUBSALICYLATE. There are 11 other brand versions of BISMUTH SUBSALICYLATE.

What is the NDC code for Stomach Relief - Regular Strength 525 mg/30mL?

The NDC (National Drug Code) for Stomach Relief - Regular Strength 525 mg/30mL is 76281-537, listed by AptaPharma Inc..

Product NDC

76281-537

Package NDC

76281-537-25

Other Bismuth Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)