FDA Label for Stomach Relief, Maximum Strength
View Indications, Usage & Precautions
- OTHER
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PRINCIPAL DISPLAY PANEL
Stomach Relief, Maximum Strength Product Label
The following document was submitted to the FDA by the labeler of this product Aptapharma Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Allergy alert: Contains salicylate. Do not take if you are
■ allergic to salicylates (including aspirin)
■ taking other salicylate products
Otc - Active Ingredient
Active ingredient
(in each 30 mL dose cup or 2 tablespoons)
Bismuth subsalicylate 1050 mg
Otc - Purpose
Purposes
Bismuth subsalicylate .............. Upset stomach reliever
and antidiarrheal
Indications & Usage
Uses relieves ■ travelers' diarrhea ■ diarrhea
■ upset stomach due to overindulgence of food and drink
including: ■ heart burn ■ indigestion ■ nausea ■ gas
■ belching
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.
Otc - Do Not Use
Do not use if you have ■ an ulcer
■ a bleeding problem ■ black or bloody stool
Otc - Ask Doctor
Ask a doctor before use if you have
■ fever ■ mucus in stool
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are
taking any drug for ■ anticoagulation (thinning of the blood)
■ diabetes ■ gout ■ arthritis
Otc - When Using
When using this product a temporary, but harmless,
darkening of the stool and/or tongue may occur
Otc - Stop Use
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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast feeding, ask health professional before use.
Otc - 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.
Dosage & Administration
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 adoctor
■ drink plenty of clear fluids to help prevent dehydration
caused by diarrhea
Other Safety Information
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 Ingredient
Inactive ingredients benzoic acid, D&C red #22,
D&C red # 28, flavor, purified water, saccharin sodium,
salicylic acid, sodium salicylate, xantham gum
Otc - Questions
Questions? 1-877-798-5944
Principal Display Panel
AP SAFE® NDC 76281-558-25
*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
6 FL OZ (177 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-13
Pennsauken, NJ 081
LOT. EXP.
res
* Please review the disclaimer below.