CALCIUM CARBONATE (ANTACID)- calcium carbonate tablet

Calcium Carbonate by

Drug Labeling and Warnings

Calcium Carbonate by is a Otc medication manufactured, distributed, or labeled by Pharbest Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Calcium carbonate 10 gr (648 mg, USP)

Purpose

Antacid

Uses

for relief of

• acid indigestion
• heartburn
• sour stomach
• upset stomach associated with these symptoms

Warnings

Ask a doctor or pharmacist before use if

you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.

If pregnant or nursing a baby,

ask a health professional before use.

Keep out of the reach of children.

Direction

• take one to four tablets daily
• do not take more than 4 tablets in a 24 hour period
• do not use the maximum dosage for more than 2 weeks 
  

Other information

• each tablet contains: calcium 260 mg
• store at controlled room temperature 150 to 300c (590 to 860F)
  
• use by expiration date on package

Inactive ingredients

microcrystalline cellulose, croscarmellose sodium, stearic acid, magnesium stearate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CALCIUM CARBONATE   (ANTACID)
calcium carbonate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 16103-377
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D, CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CARBONATE	648 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
STEARIC ACID (UNII: 4ELV7Z65AP)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	PH046
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 16103-377-08	100 in 1 BOTTLE, PLASTIC
2	NDC: 16103-377-11	1000 in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	11/29/2006

Labeler - Pharbest Pharmaceuticals Inc. (557054835)

Establishment
Name	Address	ID/FEI	Business Operations
Pharbest Pharmaceuticals Inc.		557054835	manufacture(16103-377) , pack(16103-377) , label(16103-377)