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
- Marketing Status: OTC monograph final
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.
Updated December 23, 2019
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- SPL UNCLASSIFIED SECTION
- Active Ingredient
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.
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 drugs for:
- anticoagulation (thinning the blood)
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.
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
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL - 10 Packet Carton
INGREDIENTS AND APPEARANCE
bismuth subsalicylate powder
Product 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) 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 FINAL part335 01/02/2004 Labeler - ProMex LLC (789974388)