ESTOMAQUIL POLVO- bismuth subsalicylate powder 
ProMex LLC

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Estomaquil® Polvo

Drug Facts

Active ingredient (in each pouch)

Bismuth Subsalicylate 262 mg

Purpose

Upset stomach reliever / Antidiarrheal

Uses

relieves:

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

Directions

Other information

Inactive ingredients

anhydrous citric acid, calcium carbonate, magnesium hydroxide, maltodextrin, silicon dioxide, sodium bicarbonate, tartaric acid

Distributed By:
PRO-MEX®
P.O. Box 63-0716
Miami, FL. 33163

PRINCIPAL DISPLAY PANEL - 3.0 g Pouch Carton

ESTOMAQUIL®

Bismuth Subsalicylate 262 mg

Relief for:

Maximum Strength

10 Pouches
0.1 oz (3.0 g) Each

Principal Display Panel - 3.0 g Pouch Carton
ESTOMAQUIL POLVO 
bismuth subsalicylate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58988-1080
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE262 mg
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58988-1080-110 in 1 CARTON01/02/2004
11 in 1 POUCH; Type 0: Not a Combination Product
2NDC:58988-1080-220 in 1 CARTON01/02/2004
21 in 1 POUCH; Type 0: Not a Combination Product
3NDC:58988-1080-350 in 1 CARTON01/02/2004
31 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph drugM00801/02/2004
Labeler - ProMex LLC (789974388)

Revised: 11/2023
Document Id: b60909fc-e262-4ad4-bb96-e09b71b38e1c
Set id: cf94c99a-c489-45ec-bb13-3e6959e377de
Version: 4
Effective Time: 20231129
 
ProMex LLC