ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE - aluminum hydroxide, magnesium carbonate tablet, chewable 
Simpex Pharma Pvt. Ltd

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Aluminum hydroxide and Magnesium carbonate

Drug Facts

Active ingredient (in each tablet)

Aluminum hydroxide, 160 mg

Magnesium carbonate, 105 mg

Purpose

Antacid

Uses

Relieves acid indigestion leading to

Warnings

Ask a doctor before use if you have

  • kidney disease
  • a magnesium or sodium-restricted diet

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 16 tablets in a 24-hour period or use the maximum dosage for more than 2 weeks

Keep out of reach of children.

Directions

Other information

Inactive ingredients

alginic acid, calcium stearate, color red iron oxide, flavor (mint), maize starch, magnesium oxide, mannitol, sodium bicarbonate, sucrose

Package Labeling:

Label

ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE  
aluminum hydroxide, magnesium carbonate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76457-001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE160 mg
MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D) MAGNESIUM CARBONATE105 mg
Inactive Ingredients
Ingredient NameStrength
ALGINIC ACID (UNII: 8C3Z4148WZ)  
CALCIUM STEARATE (UNII: 776XM7047L)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
STARCH, CORN (UNII: O8232NY3SJ)  
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
MANNITOL (UNII: 3OWL53L36A)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
Colororange (orange) Score2 pieces
ShapeROUND (round biconvex film-coated tablet plain from both sides) Size13mm
FlavorImprint Code ;
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76457-001-001 in 1 CARTON02/09/2018
1100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00102/09/2018
Labeler - Simpex Pharma Pvt. Ltd (916758275)
Registrant - Simpex Pharma Pvt. Ltd (916758275)
Establishment
NameAddressID/FEIBusiness Operations
Simpex Pharma Pvt. Ltd916758275manufacture(76457-001)

Revised: 11/2023
Document Id: 0b5850de-34f4-b95e-e063-6294a90affe1
Set id: e799a555-bfd0-4298-a5dc-aeb671815d40
Version: 7
Effective Time: 20231129
 
Simpex Pharma Pvt. Ltd