ESTOMAROL  - aluminum hydroxide, bismuth subcarbonate, calcium carbonate, magnesium carbonate and sodium bicarbonate powder 
Laboratorios Imperiales, S.A. de C.V.

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Estomarol Antacid Powder

Drug Facts

Active Ingredients

In each pack

Aluminum Hydroxide 0.18g

Bismuth Subcarbonate 0.21g

Calcium Carbonate 0.25g

Magnesium Carbonate 0.59g

Sodium Bicarbonate 2.27g

Purpose

Antacid

Uses

• For the relief of heartburn, sour stomach, and acid indigestion
  

Directions

Add packet (3.5g) to a cup of water after each meal taken, maximum of 6 doses in 24 hours or as directed by a physician.

Other information

In each pack:

Calcium 95mg, Magnesium 145mg, and Sodium 605mg.

Inactive Ingredients

Colloidal silicon dioxide, glycerine anyhydrous, peppermint oil

Warnings

• Ask a doctor or pharmacist before use if you are now taking a prescription drug. Antacids may interact with certain prescription drugs.
  

When using this product

• Do not take more than 6 doses in 24-hour period, or use more than 2 weeks, except under the advice and supervision of a physician.
• Do not use this product except under the advice and supervision of a physician if you have kidney disease or are on a sodium restricted diet.
• Do not take this product if you are presently taking a prescription antibiotic drug containing any form of tetracycline.
• Do not use if you are pregnant or lactating.
• Use caution in patients who are taking anticoagulants or who are diabetic.
• Do not administer to adolescents who have or have recently had chicken pox
• This medication can cause constipation and in large doses can cause diarrhea, dark urine and dark bowel movements.
• Do not give to children under 6

Keep out of reach of children.

Estomarol

Antacid Powder

LIMSA

15-0.12 oz packets (3.5g) - Net Wt. 1.9 oz (52.5 g)

ESTOMAROL  aluminum hydroxide, bismuth subcarbonate, calcium carbonate, magnesium carbonate, sodium bicarbonate   powder

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 57465-100 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALUMINUM HYDROXIDE (ALUMINUM CATION) ALUMINUM HYDROXIDE 0.18 g  in 3.5 g BISMUTH SUBCARBONATE (BISMUTH CATION) BISMUTH SUBCARBONATE 0.21 g  in 3.5 g CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CARBONATE 0.25 g  in 3.5 g MAGNESIUM CARBONATE (MAGNESIUM CATION) MAGNESIUM CARBONATE 0.59 g  in 3.5 g SODIUM BICARBONATE (SODIUM CATION) SODIUM BICARBONATE 2.27 g  in 3.5 g

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE   GLYCERIN

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 57465-100-00 15 PACKET In 1 BOX contains a PACKET 1 3.5 g In 1 PACKET This package is contained within the BOX (57465-100-00)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	05/11/2011

Labeler - Laboratorios Imperiales, S.A. de C.V. (812643138)

Establishment
Name	Address	ID/FEI	Operations
Laboratorios Imperiales, S.A. de C.V.		812643138	manufacture

Revised: 05/2011Laboratorios Imperiales, S.A. de C.V.