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Stomach Relief by Aurohealth LLC

Medically reviewed on July 15, 2017

Dosage form: liquid
Ingredients: BISMUTH SUBSALICYLATE 525mg in 30mL
Labeler: Aurohealth LLC
NDC Code: 58602-302

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 525 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
    • fullness

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 1/2 to 1 hour as needed
  • do not exceed 8 doses (240 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 233 mg
  • 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.

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

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8 FL OZ (236 mL) Bottle

AUROHEALTH
NDC 58602-302-20
Stomach Relief
Bismuth Subsalicylate Liquid
Upset Stomach Reliever/
Antidiarrheal
Each 30 mL dose of oral solution contains:
525 mg - Bismuth subsalicylate
5 Symptom Digestive Relief:

  • Heartburn
  • Indigestion
  • Nausea
  • Upset stomach
  • Diarrhea

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



STOMACH RELIEF 
stomach relief liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-302
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (SALICYLIC ACID and BISMUTH CATION) BISMUTH SUBSALICYLATE525 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID 
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:58602-302-20236 mL in 1 BOTTLE
2NDC:58602-302-16354 mL in 1 BOTTLE
3NDC:58602-302-26473 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(58602-302)

 
Aurohealth LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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