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

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.

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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

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

When using this product

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)


EstomarolPacket


EstomarolA


EstomarolB


EstomarolC

EstomarolD

ESTOMAROL 
aluminum hydroxide, bismuth subcarbonate, calcium carbonate, magnesium carbonate, sodium bicarbonate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57465-100
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE0.18 g  in 3.5 g
BISMUTH SUBCARBONATE (UNII: M41L2IN55T) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBCARBONATE0.21 g  in 3.5 g
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE0.25 g  in 3.5 g
MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D) MAGNESIUM CARBONATE0.59 g  in 3.5 g
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM BICARBONATE2.27 g  in 3.5 g
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57465-100-0015 in 1 BOX05/11/2011
13.5 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33105/11/2011
Labeler - Laboratorios Imperiales, S.A. de C.V. (812643138)
Establishment
NameAddressID/FEIBusiness Operations
Laboratorios Imperiales, S.A. de C.V.812643138manufacture(57465-100)

Revised: 12/2019
Document Id: 9a73c6d0-db6a-8a66-e053-2995a90a6db6
Set id: 7a1bc8d6-ce04-4ee6-bfa8-7fe087155975
Version: 3
Effective Time: 20191224
 
Laboratorios Imperiales, S.A. de C.V.