Drugplain

PEPT-ACHE 262 mg/1

BISMUTH SUBSALICYLATE · TABLET, CHEWABLE · JHK Inc dba American Safety & First Aid

No Recall History
Plain English

Bismuth subsalicylate is an over-the-counter oral medication used to relieve symptoms of heartburn, indigestion, and upset stomach. It works by reducing inflammation in the stomach and intestines and can also help with diarrhea and nausea.

Key Facts

Brand Name
PEPT-ACHE
Generic Name
BISMUTH SUBSALICYLATE
NDC Code (Product)
73598-1232
Manufacturer
JHK Inc dba American Safety & First Aid
Strength
262 mg/1
Dosage Form
TABLET, CHEWABLE
Route
ORAL
Marketing Status
Application #
M008
Drug Class
Bismuth [EPC]
Marketing Start
02/02/2000

Recall History

No Recall History

Side Effects Reported to FDA

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

nausea89 reports
vomiting72 reports
diarrhoea69 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

Use temporarily relieves: controls diarrhea relieves heartburn, indigestion, nausea and upset stomach without constipating

Dosage & Administration

Directions do not use more than directed chew or dissolve in mouth use until diarrhea stops but not more than 2 days drink plenty of clear fluids to help prevent dehydration, which may accompany diarrhea do not exceed 16 tablets in 24 hours Adults and children: (12 years and older) Chew 2 tablets every 1/2 to 1 hour or 4 tablets every hour as needed Children under 12 years: ask a doctor

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 and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's Syndrome, a rare but serious illness. Allergy Warning Contains salicylate. Do not take if you are: allergic to salicylates (including aspirin) taking other salicylate products Do not use if you have bloody or black stool an ulcer a bleeding problem Ask a doctor before use if you have fever mucus in the stool Ask a doctor or pharmacist before use if you are taking a prescription drug for: anticoagulation (thinning of the blood) diabetes gout arthritis Stop use and ask a doctor if symptoms get worse ringing in the ears or loss of hearing occurs diarrhea lasts more than two days When using this product: a temporary, but harmless darkening of the stool and/or tongue may occur. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control Center right away.

Frequently Asked Questions

What is PEPT-ACHE used for?

Bismuth subsalicylate is an over-the-counter oral medication used to relieve symptoms of heartburn, indigestion, and upset stomach. It works by reducing inflammation in the stomach and intestines and can also help with diarrhea and nausea.

Is PEPT-ACHE a controlled substance?

PEPT-ACHE is not classified as a controlled substance by the DEA.

What is the generic name for PEPT-ACHE?

The generic name for PEPT-ACHE is BISMUTH SUBSALICYLATE. There are 11 other brand versions of BISMUTH SUBSALICYLATE.

What is the NDC code for PEPT-ACHE 262 mg/1?

The NDC (National Drug Code) for PEPT-ACHE 262 mg/1 is 73598-1232, listed by JHK Inc dba American Safety & First Aid.

Product NDC

73598-1232

Package NDC

73598-1232-1

Other Bismuth Brands

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

Data from openFDA · Public domain (CC0 1.0)