STOMACH RELIEF, MAXIMUM STRENGTH- bismuth subsalicylate suspension 
AptaPharma Inc.

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Stomach Relief - Maximum Strength

Drug Facts

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.

Allergy alert: Contains salicylate. Do not take if you are
■ allergic to salicylates (including aspirin)
■ taking other salicylate products

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 adoctor
■ 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 104ºF or 40ºC) ■ 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

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.

558-25 6OZ

res

STOMACH RELIEF, MAXIMUM STRENGTH 
bismuth subsalicylate suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76281-558
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE1050 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorpinkScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76281-558-25177 mL in 1 BOTTLE; Type 0: Not a Combination Product09/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00809/30/2020
Labeler - AptaPharma Inc. (790523323)
Registrant - AptaPharma Inc. (790523323)
Establishment
NameAddressID/FEIBusiness Operations
AptaPharma Inc.790523323manufacture(76281-558)

Revised: 12/2023
Document Id: 22de45fb-431e-41c3-aafc-f9d8655dc60a
Set id: cdd436f6-b769-49aa-9e6c-da512da9e6e3
Version: 2
Effective Time: 20231230
 
AptaPharma Inc.