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Estomaquil Polvo

Dosage form: powder
Ingredients: BISMUTH SUBSALICYLATE 262mg
Labeler: ProMex LLC
NDC Code: 58988-1080

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.

Estomaquil® Polvo

DRUG FACTS

Active Ingredient

Bismuth Subsalicylate: Each pouch contains 262 mg

Purpose

Upset Stomach reliever / Antidiarrheal

Uses

Relieves:

  • upset stomach
  • indigestion
  • diarrhea
  • heartburn
  • nausea

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 or vomiting occur, consult a doctor 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 salicylate (including aspirin)
  • taking other salicylate products

Do not use if you have

  • an ulcer
  • bleeding problem
  • bloody or black 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 drugs 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
  • ringing in ears or loss of hearing occurs
  • if diarrhea lasts more than 2 days.

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

Keep out of the reach of children. In case of overdose, seek professional help or contact a poison control center immediately.

Directions

Adults & Children 12 yrs or older: Dissolve 2 pouches in 1/2 glass of water. Repeat every 1/2 to 1 hour as needed, to a maximum of 8 doses in a 24-hour period.

  • use until diarrhea stops, but not more than 2 days, If symptoms persist, consult a doctor.
  • Drink plenty of clear fluids to help prevent dehydration which may accompany diarrhea.
  • Children under 12 yrs ask a doctor.

Other Information
  • Avoid excessive heat
  • Each pouch contains: sodium 223mg

Inactive Ingredients

calcium carbonate, citric acid, magnesium hydroxide, sodium bicarbonate, tartaric acid

PRINCIPAL DISPLAY PANEL - 10 Packet Carton

ESTOMAQUIL®

Relief for:

  • Nausea
  • Heartburn
  • Diarrhea
  • Fullness

Maximum Strength

10 Packets

ESTOMAQUIL POLVO 
bismuth subsalicylate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58988-1080
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (SALICYLIC ACID) BISMUTH SUBSALICYLATE262 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE 
CITRIC ACID MONOHYDRATE 
MAGNESIUM HYDROXIDE 
SODIUM BICARBONATE 
TARTARIC ACID 
Packaging
#Item CodePackage Description
1NDC:58988-1080-110 POUCH in 1 CARTON
11 POWDER in 1 POUCH
2NDC:58988-1080-220 POUCH in 1 CARTON
21 POWDER in 1 POUCH
3NDC:58988-1080-350 POUCH in 1 CARTON
31 POWDER in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33501/02/2004
Labeler - ProMex LLC (789974388)

 
ProMex LLC

Medically reviewed on Nov 6, 2018

Further information

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

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