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Stomach Relief Maximum Strength

Dosage form: liquid
Ingredients: BISMUTH SUBSALICYLATE 1050mg in 30mL
Labeler: Aurohealth LLC
NDC Code: 58602-301

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.

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 - 8 FL OZ (236 mL) Bottle

AUROHEALTH
NDC 58602-301-20
Stomach Relief
MAXIMUM STRENGTH
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

*Compare to the active ingredient
in Pepto-BismolTM Max Strength
Original Flavor
8 FL OZ
(236 mL)

STOMACH RELIEF MAXIMUM STRENGTH 
bismuth subsalicylate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-301
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (SALICYLIC ACID and BISMUTH CATION) BISMUTH SUBSALICYLATE1050 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID 
METHYL SALICYLATE 
D&C RED NO. 22 
D&C RED NO. 28 
MAGNESIUM ALUMINUM SILICATE TYPE IC 
SACCHARIN SODIUM 
SALICYLIC ACID 
SODIUM SALICYLATE 
SORBIC ACID 
WATER 
XANTHAN GUM 
Product Characteristics
ColorPINK (Pink to Bright Pink) Score    
ShapeSize
FlavorWINTERGREENImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:58602-301-20236 mL in 1 BOTTLE
2NDC:58602-301-16354 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33504/01/2017
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIOperations
Aurohealth LLC078728447MANUFACTURE(58602-301)

 
Aurohealth LLC

← See all Stomach Relief Maximum Strength brands

Medically reviewed on Apr 1, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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