CALCIUM CARBONATE tablet, chewable

CALCIUM CARBONATE by

Drug Labeling and Warnings

CALCIUM CARBONATE by is a Otc medication manufactured, distributed, or labeled by Blessings International, Geri-Care Pharmaceutical Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Calcium Carbonate 500 mg

Purpose

Antacid

Uses

temporarily relieves:

• acid indigestion
• heartburn
• sour stomach

Warnings

Ask a doctor before use if you

• have kidney disease
• are taking prescription drugs; antacids may interact with certain prescription drugs

Stop use and ask a doctor if symptoms last more than 2 weeks.

When using this product do not use the maximum dosage for more than 2 weeks

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Directions

For adults and children 12 years and older, chew 2-4 tablets as symptoms occur

• repeat hourly if symptoms return, or as directed by a physician
• do not take more than 15 tablets in a 24 hour period
• children under 12 years: consult a doctor

Other information

• each tablet contains: calcium 200 mg
• store at room temperature

Inactive ingredients

assorted flavors, dextrose, D&C Yellow #10 lake, FD&C Blue #1 lake, FD&C Red #40 lake, FD&C Yellow #6 lake, magnesium stearate, maltodextrin. May also contain cellulose, FD&C Yellow #5 lake (tartrazine), stearic acid, sugar.

Package label

INGREDIENTS AND APPEARANCE

CALCIUM CARBONATE 
calcium carbonate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51376-127
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D)	CALCIUM CARBONATE	500 mg

Inactive Ingredients
Ingredient Name	Strength
DEXTROSE (UNII: IY9XDZ35W2)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
MAGNESIUM STEARATE (UNII: 70097M6I30)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
STEARIC ACID (UNII: 4ELV7Z65AP)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Characteristics
Color	red, green, orange, yellow	Score	no score
Shape	ROUND	Size	14mm
Flavor	CHERRY, LIME, ORANGE, LEMON	Imprint Code	AZ;024
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51376-127-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	04/01/2015

Labeler - Blessings International (064965742)

Registrant - Geri-Care Pharmaceutical Corp (611196254)

Establishment
Name	Address	ID/FEI	Business Operations
Geri-Care Pharmaceutical Corp		611196254	repack(51376-127)