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Drug Facts
Pept-ache Tablet, Chewable
FDA Label NDC 73598-1232
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jhk Inc Dba American Safety & First Aid for the product Pept-ache (NDC 73598-1232). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient (in each tablet), purpose, use, reye's syndrome, allergy warning, do not use if you have, ask a doctor before use if you have, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Tablet)
Bismuth subsalicylate 262 mg (each tablet contains 102 mg salicylate)
Purpose
Antidiarrheal/Antacid
Use
temporarily relieves:
- controls diarrhea
- relieves heartburn, indigestion, nausea and upset stomach without constipating
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
Otc - Ask Doctor/Pharmacist
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
Otc - When Using
When using this product: a temporary, but harmless darkening of the stool and/or tongue may occur.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control Center right away.
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
Other Information
- phenylketonurics: contains phenylalanine 1.1mg per tablet
- each tablet contains 73mg elemental calcium
- store at room temperature 59°-86°F (15°-30°C)
- tamper-evident sealed packets do not use if packet is opened or torn
Inactive Ingredients
acacia gum, aspartame, calcium carbonate, D&C red #27, dextrates, flavoring, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide
Questions?
1-866-651-3660 Monday-Friday 8:00am-5:00pm EST
Principal Display Panel - 36 Tablet Packet Box
This product is not manufactured or distributed by Proctor & Gamble
Owner of the registered trademark Pepto-Bismol®.
Pept-Ache
Anti-Diarrheal
- Temporary relief from upset stomach
- Soothes nausea, heartburn and
indigestion - Chewable tablets
These quality comfort tablets are formulated and packaged for use in
the workplace and meet ANSI Z308. 1-2015 standards. They are
sealed in tamper-evident packets for safety and convenience.
36 Tablets • 1 Tablet Per Packet
Principal Display Panel (36 Tablet Packet Box)
* Please review the disclaimer below.
