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

Estomarol by

Drug Labeling and Warnings

Estomarol by is a Otc medication manufactured, distributed, or labeled by Laboratorios Imperiales, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

Purpose

Antacid

INDICATIONS & USAGE

Uses

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

DOSAGE & ADMINISTRATION

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.

SPL UNCLASSIFIED SECTION

Other information

In each pack:

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

INACTIVE INGREDIENT

Inactive Ingredients

Colloidal silicon dioxide, glycerine anyhydrous, peppermint oil

WARNINGS

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

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

Keep out of reach of children.

PRINCIPAL DISPLAY PANEL

Estomarol

Antacid Powder

LIMSA

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

INGREDIENTS AND APPEARANCE

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

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0)	ALUMINUM HYDROXIDE	0.18 g  in 3.5 g
BISMUTH SUBCARBONATE (UNII: M41L2IN55T) (BISMUTH CATION - UNII:ZS9CD1I8YE)	BISMUTH SUBCARBONATE	0.21 g  in 3.5 g
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CARBONATE	0.25 g  in 3.5 g
MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D)	MAGNESIUM CARBONATE	0.59 g  in 3.5 g
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM BICARBONATE	2.27 g  in 3.5 g

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57465-100-00	15 in 1 BOX	05/11/2011
1		3.5 g in 1 PACKET; Type 0: Not a Combination Product

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	Business Operations
Laboratorios Imperiales, S.A. de C.V.		812643138	manufacture(57465-100)