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Estomarol

Medically reviewed on November 9, 2017.

Dosage form: powder
Ingredients: ALUMINUM HYDROXIDE 0.18g in 3.5g, BISMUTH SUBCARBONATE 0.21g in 3.5g, CALCIUM CARBONATE 0.25g in 3.5g, MAGNESIUM CARBONATE 0.59g in 3.5g, SODIUM BICARBONATE 2.27g in 3.5g
Labeler: Laboratorios Imperiales, S.A. de C.V.
NDC Code: 57465-100

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.

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:57465-100
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALUMINUM HYDROXIDE (ALUMINUM CATION) ALUMINUM HYDROXIDE0.18 g  in 3.5 g
BISMUTH SUBCARBONATE (BISMUTH CATION) BISMUTH SUBCARBONATE0.21 g  in 3.5 g
CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CARBONATE0.25 g  in 3.5 g
MAGNESIUM CARBONATE (MAGNESIUM CATION) MAGNESIUM CARBONATE0.59 g  in 3.5 g
SODIUM BICARBONATE (SODIUM CATION) SODIUM BICARBONATE2.27 g  in 3.5 g
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
GLYCERIN 
Packaging
#Item CodePackage Description
1NDC:57465-100-0015 PACKET (PACKET) in 1 BOX
13.5 g in 1 PACKET
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/FEIOperations
Laboratorios Imperiales, S.A. de C.V.812643138manufacture

 
Laboratorios Imperiales, S.A. de C.V.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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