Label: STOMACH RELIEF, MAXIMUM STRENGTH- bismuth subsalicylate suspension
- NDC Code(s): 76281-558-25
- Packager: AptaPharma Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 30, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
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. - SPL UNCLASSIFIED SECTION
- DO NOT USE
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
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
- INACTIVE INGREDIENT
- QUESTIONS
-
Principal Display Panel
AP SAFE® NDC 76281-558-25
*COMPARE TO
the active ingredient in
PEPTO-BISMOL™
MAXIMUM STRENGTHStomach
Relief
Bismuth Subsalicylate
Antidiarrheal/Upset Stomach RelieverMaximum Strength
5 Symptom Relief of:
● Nausea ● Heartburn ●Indigestion
● Upset stomach ● Diarrhea6 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 081LOT. EXP.
res
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INGREDIENTS AND APPEARANCE
STOMACH RELIEF, MAXIMUM STRENGTH
bismuth subsalicylate suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76281-558 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE 1050 mg in 30 mL Inactive Ingredients Ingredient Name Strength BENZOIC ACID (UNII: 8SKN0B0MIM) D&C RED NO. 22 (UNII: 1678RKX8RT) D&C RED NO. 28 (UNII: 767IP0Y5NH) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SALICYLIC ACID (UNII: O414PZ4LPZ) SODIUM SALICYLATE (UNII: WIQ1H85SYP) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color pink Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76281-558-25 177 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M008 09/30/2020 Labeler - AptaPharma Inc. (790523323) Registrant - AptaPharma Inc. (790523323) Establishment Name Address ID/FEI Business Operations AptaPharma Inc. 790523323 manufacture(76281-558)