Drug Labeling and Warnings

Drug Details

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BISMUTH SUBSALICYLATE MAXIMUM STRENGTH STOMACH RELIEF - bismuth subsalicylate liquid 
Aurohealth LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient (in each 30 mL dose cup)

Bismuth subsalicylate 1050 mg

Purposes

Upset stomach reliever and antidiarrheal

Uses

relieves

  • travelers’ diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink, including:
    • heartburn
    • 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
  • bloody or black stool

Ask a doctor before use if you have

  • fever
  • mucus in the stool

Ask a doctor or pharmacist before use if you are taking any drug for

  • anticoagulation (thinning the blood)
  • diabetes
  • gout
  • arthritis

When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur

Stop use and ask a doctor if

  • symptoms get worse or last more than 2 days
  • ringing in the ears or loss of hearing occurs
  • diarrhea lasts more than 2 days

If pregnant or breast feeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

  • shake well before use
  • mL=milliliter
  • measure only with dosing cup provided. Do not use any other dosing device.
  • adults and children 12 years and over: 1 dose (30 mL) every hour as needed
  • do not exceed 4 doses (120 mL) 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: magnesium 12 mg, sodium 7 mg
  • salicylate 449 mg
  • sugar free
  • low sodium
  • Store at 20° to 25°C (68° to 77°F) and protect from freezing
  • avoid excessive heat (over 104°F or 40°C)
  • TAMPER EVIDENT: Do not use if the printed seal under the cap is missing or broken.

Inactive ingredients

benzoic acid, D&C red No.22, D&C red No. 28, flavor, magnesium aluminum silicate type 1C, purified water, saccharin sodium, salicylic acid, sodium salicylate, sorbic acid, xanthan gum

Questions or comments?

1-855-274-4122
 
* This product is not manufactured or distributed by Procter & Gamble, distributor of Pepto-BismolTM Max Strength.

Distributed by:
Aurohealth LLC.
2572 Brunswick Pike,
Lawrenceville, NJ 08648

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 12 FL OZ (354 mL) Bottle

NDC: 58602-519-16
PrimaryHealth
COMPARE TO in Pepto-BismolTM
Max Strength active ingredient*

MAXIMUM STRENGTH

Stomach Relief

Bismuth Subsalicylate Liquid
Upset Stomach Reliever /
Antidiarrheal

Each 30 mL dose of oral solution contains:
1050 mg - Bismuth subsalicylate

5 Symptom Digestive Relief: 

  • Heartburn
  • Indigestion
  • Nausea
  • Upset stomach
  • Diarrhea

Original Flavor

12 FL OZ (354 mL)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 12 FL OZ (354 mL) Bottle

BISMUTH SUBSALICYLATE MAXIMUM STRENGTH STOMACH RELIEF 
bismuth subsalicylate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 58602-519
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ, BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBSALICYLATE1050 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID (UNII: 8SKN0B0MIM)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
D&C RED NO. 22 (UNII: 1678RKX8RT)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
MAGNESIUM ALUMINUM SILICATE TYPE IC (UNII: XLI9KNX1FT)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
SODIUM SALICYLATE (UNII: WIQ1H85SYP)  
SORBIC ACID (UNII: X045WJ989B)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorPINK (Pink to Bright Pink) Score    
ShapeSize
FlavorWINTERGREENImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 58602-519-16354 mL in 1 BOTTLE; Type 0: Not a Combination Product09/20/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33509/20/2018
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurohealth LLC078728447MANUFACTURE(58602-519)

Revised: 9/2018
 
Aurohealth LLC


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