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Estomax

Dosage form: liquid
Ingredients: BISMUTH SUBSALICYLATE 262mg in 15mL
Labeler: Pharmadel LLC
NDC Code: 55758-305

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.

Active ingredient (in each 15 mL tbsp)
Bismuth subsalicylate 262 mg.................................Upset stomach reliever and antidiarrheal

Purpose

Upset stomich reliever and antidiarrheal

Uses

Relieves

  • diarrhea
  • upset stomach due to over indulgance 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 occur, consult a doctor because these symptoms could be an early sign of Reyes's syndrome, a rare but serious illness.

Allergy allert: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 doctor before use if you have

  • a fever
  • mucus in the stool

Ask 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 temporarily, but harmless, darkening of the stooland/or tongue may occur.

Stop use and ask a doctor if

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

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

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

  • Shake well before use
  • for accurate dosing, use dose cup
  • Adults and children 12 years and over: 1 dose (2 tbsp or 30 mL) every 1/2 hour to 1 hour as needed
  • Do not exceed 8 doses (16 tbsp or 240 mL) in 24 hours
  • Children under 12 years: consult a doctor
  • Drink plenty of water or clear fluids to help prevent dehydration caused by diarrhea

Other information

  • each tablespoon contains: sodium 6 mg
  • Low sodium
  • Sugar free
  • Salicylate 130 mg
  • Protect from freezing
  • Avoid excessive heat (more than 104° F or 40° C)
  • Tamper-Evident: Do not use if imprinted cello-band is torn, broken or missing

Inactive ingredients

benzoic acid, D&C red #22, D&C red #28, flavor, kaolin, magnesium aluminum silicate, salicylic acid, sodium saccharin, sodium salicylate, sorbic acid, sucralose, water, xanthan gum

Questions?

call 1-800-359-3478 M-F 9 AM to 5 PM Eastern Time

ESTOMAX 
bismuth subsalicylate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-305
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (SALICYLIC ACID) BISMUTH SUBSALICYLATE262 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID 
D&C RED NO. 22 
D&C RED NO. 28 
KAOLIN 
MAGNESIUM 
ALUMINUM SILICATE 
SALICYLIC ACID 
SACCHARIN SODIUM ANHYDROUS 
SODIUM SALICYLATE 
SORBIC ACID 
SUCRALOSE 
WATER 
XANTHAN GUM 
Packaging
#Item CodePackage Description
1NDC:55758-305-081 BOTTLE in 1 CARTON
1240 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33502/21/2012
Labeler - Pharmadel LLC (026095439)

Revised: 10/2013
 
Pharmadel LLC

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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