ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE- aluminum hydroxide, magnesium carbonate tablet, chewable

Aluminum hydroxide and Magnesium carbonate by

Drug Labeling and Warnings

Aluminum hydroxide and Magnesium carbonate by is a Otc medication manufactured, distributed, or labeled by Simpex Pharma Pvt. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each tablet)

Aluminum hydroxide, 160 mg

Magnesium carbonate, 105 mg

Purpose

Antacid

Uses

Relieves acid indigestion leading to

• stomach upset
• heart burn
  

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

• chew 2 to 4 tablets four times a day or as directed by a doctor
• take after meals and at bedtime or as needed
• for best results follow by a half glass of water or other liquid
• do not swallow whole
  

Other information

• each tablet contains: magnesium 50 mg and sodium 32 mg
• store at 20°-25°C

Inactive ingredients

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

Package Labeling:

INGREDIENTS AND APPEARANCE

ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE  
aluminum hydroxide, magnesium carbonate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76457-001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0)	ALUMINUM HYDROXIDE	160 mg
MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D)	MAGNESIUM CARBONATE	105 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	orange (orange)	Score	2 pieces
Shape	ROUND (round biconvex film-coated tablet plain from both sides)	Size	13mm
Flavor		Imprint Code	;
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76457-001-00	1 in 1 CARTON	02/09/2018
1		100 in 1 BOTTLE; 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	02/09/2018

Labeler - Simpex Pharma Pvt. Ltd (916758275)

Registrant - Simpex Pharma Pvt. Ltd (916758275)

Establishment
Name	Address	ID/FEI	Business Operations
Simpex Pharma Pvt. Ltd		916758275	manufacture(76457-001)