CALCIUM CARBONATE tablet, chewable

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D)

Available from:

Blessings International

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antacid temporarily relieves: - acid indigestion - heartburn - sour stomach

Authorization status:

OTC monograph final

Summary of Product characteristics

CALCIUM CARBONATE- CALCIUM CARBONATE TABLET, CHEWABLE
BLESSINGS INTERNATIONAL
----------
763-BLE
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 stones.
ASK A DOCTOR BEFORE USE IF YOU 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
IF PREGNANT OR BREAST FEEDING, ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help
or contact a
Poison Control Center right away.
DIRECTIONS
• do not exceed recommended dose
• adults and children 12 years of age and older:
• chew 2 to 4 tablets as symptoms occur, or as directed by a doctor
• do not take more than 15 tablets in 24 hours
• if pregnant, do not take more than 10 tablets in 24 hours
• children under 12 years: ask a doctor
OTHER INFORMATION
EACH TABLET CONTAINS: calcium 200 mg
Store below 30°C (86°F). Keep the container tightly closed.
Tamper Evident: Do not use if imprinted seal under cap is
missing or broken.
INACTIVE INGREDIENTS
assorted flavors, D&C Yellow #10 lake, dextrose, FD&C Blue #1 lake,
FD&C Red #40
lake, FD&C Yellow #6 lake, magnesium stearate, maltodextrin
PACKAGE LABEL
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
Blessings International
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 N