Estomaquil Polvo
Estomaquil Polvo is an FDA drug label for the active ingredient BISMUTH SUBSALICYLATE manufactured by ProMex LLC administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231129.
Generic: BISMUTH SUBSALICYLATE
Manufacturer: ProMex LLC
Product Type: HUMAN OTC DRUG
Route: ORAL
Dosage Form:
NDC: 58988-1080
Application: M008
Effective: 20231129
Active Ingredients: Active ingredient (in each pouch) Bismuth Subsalicylate 262 mg
Indications & Usage
Uses relieves: travelers' diarrhea diarrhea upset stomach due to overindulgence in food and drink, including: heartburn indigestion nausea gas belching fullness
Dosage & Administration
Directions Adults & Children 12 yrs and older: Dissolve 2 pouches (1 dose) 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
Contraindications
Not available.
Warnings
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 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 salicylate (including aspirin) taking other salicylate products Do not use if you have an ulcer a bleeding problem 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 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 the reach of children. In case of overdose, seek professional help or contact a poison control center immediately
Adverse Reactions
Not available.
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