Label: ESTOMAQUIL POLVO- bismuth subsalicylate powder
- NDC Code(s): 58988-1080-1, 58988-1080-2, 58988-1080-3
- Packager: ProMex LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 29, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each pouch)
- Purpose
- Uses
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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
Ask a doctor or pharmacist before use if you are taking any drug for:
- anticoagulation (thinning the blood)
- diabetes
- gout
- arthritis
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Directions
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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
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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
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 3.0 g Pouch Carton
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INGREDIENTS AND APPEARANCE
ESTOMAQUIL POLVO
bismuth subsalicylate powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58988-1080 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE 262 mg Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE (UNII: H0G9379FGK) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) SODIUM BICARBONATE (UNII: 8MDF5V39QO) TARTARIC ACID (UNII: W4888I119H) MALTODEXTRIN (UNII: 7CVR7L4A2D) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58988-1080-1 10 in 1 CARTON 01/02/2004 1 1 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:58988-1080-2 20 in 1 CARTON 01/02/2004 2 1 in 1 POUCH; Type 0: Not a Combination Product 3 NDC:58988-1080-3 50 in 1 CARTON 01/02/2004 3 1 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph drug M008 01/02/2004 Labeler - ProMex LLC (789974388)