Other
Drug Facts
Allergy alert: Contains salicylate. Do not take if you are
■ allergic to salicylates (including aspirin)
■ taking other salicylate products
The following Structured Product Label (SPL) was submitted to the FDA by Aptapharma Inc. for the product Stomach Relief - Maximum Strength (NDC 76281-538). 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, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Allergy alert: Contains salicylate. Do not take if you are
■ allergic to salicylates (including aspirin)
■ taking other salicylate products
Active ingredient
(in each 30 mL dose cup or 2 tablespoons)
Bismuth subsalicylate 1050 mg
Purposes
Bismuth subsalicylate .............. Upset stomach reliever
and antidiarrheal
Uses relieves ■ travelers' diarrhea ■ diarrhea
■ upset stomach due to overindulgence of food and
drink including: ■ heart burn ■ indigestion
■ nausea ■ gas ■ belching
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.
Do not use if you have ■ an ulcer
■ a bleeding problem ■ black or bloody stool
Ask a doctor before use if you have
■ fever ■ mucus in stool
Ask a doctor or pharmacist before use if you are
taking any drug for ■ anticoagulation (thinning of the blood)
■ diabetes ■ gout ■ arthritis
When using this product a temporary, but harmless,
darkening of the stool and/or tongue may occur
Slop use and ask a doctor if
■ diarrhea lasts more than 2 days
■ symptoms get worse or last more than 2 days
■ ringing in the ears or loss of hearing occurs
If pregnant or breast feeding, ask 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.
Directions ■ Shake well before use
■ use dose cup or tablespoon (TBSP)
■ adults and children 12 years and over: 1 dose
(30 mL or 2 TBSP) every 1 hour as needed
■ do not exceed 4 doses (120 mL or 8 TBSP) 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 30 ml dose cup contains:
sodium 13 mg, salicylate 455 mg
■ protect from freezing ■ avoid excessive heat
(over 104°F or 40°C) ■ low sodium
Inactive ingredients benzoic acid, D&C red #22,
D&C red # 28, flavor, purified water, saccharin sodium,
salicylic acid, sodium salicylate, xantham gum
Questions? 1-877-798-5944
AP SAFE NDC 76281-538-26
*COMPARE TO
the active ingredient in
PEPTO-BISMOL™
MAXIMUM STRENGTH
Stomach
Relief
Bismuth Subsalicylate
Antidiarrheal / Upset Stomach Reliever
Maximum Strength
5 Symptom Relief of:
● Nausea ● Heartburn ●Indigestion
● Upset stomach ● Diarrhea
8 FL OZ (237 mL)
TAMPER EVIDENT: Do not use if imprinted
shrinkband is missing or broken
*This product is not manufactured or distributed by Procter & Gamble,
Inc., the distributor of Pepto-Bismol™.
Manufactured by: AptaPharma Inc., Made in USA
1533 Union Ave. AP-LR-12 REV01
Pennsauken, NJ 08110
3 76281 53826 7 PEEL
HERE
Stomach Relief - Maximun Strength by AptaPharma Inc.
res
* Please review the disclaimer below.