CALCIUM CARBONATE (ANTACID)- calcium carbonate tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Preferred Pharmaceuticals Inc.

INN (International Name):

CALCIUM CARBONATE

Composition:

CALCIUM CARBONATE 648 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antacid for relief of

Authorization status:

OTC monograph final

Summary of Product characteristics

CALCIUM CARBONATE (ANTACID)- CALCIUM CARBONATE TABLET
PREFERRED PHARMACEUTICALS INC.
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if they_
_comply with applicable regulations and policies. FDA has not
evaluated whether this product complies._
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DRUG FACTS
ACTIVE INGREDIENT (IN EACH TABLET)
Calcium carbonate 10 gr (648 mg, USP)
PURPOS E
Antacid
US ES
for relief of
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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
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OTHER INFORMATION
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INACTIVE INGREDIENTS
acid indigestion
heartburn
sour stomach
upset stomach associated with these symptoms
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
each tablet contains: calcium 260 mg
store at controlled room temperature 15 to 30 c (59 to 86 F)
0
0
0
0
use by expiration date on package
microcrystalline cellulose, croscarmellose sodium, stearic acid,
magnesium stearate
CALCIUM CARBONATE (ANTACID)
calcium carbonate tablet
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 8 78 8 -6 343(NDC:16 10 3-377)
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRE NG TH
STRE NG TH
CALCIUM CARBO NATE (UNII: H0 G9 379 FGK) (CARBONATE ION -
UNII:7UJQ5OPE7D, CALCIUM
CATION - UNII:2M8 3C4R6 ZB)
CALCIUM
CARBONATE
6 48 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)
CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )
STEARIC ACID (UNII: 4ELV7Z6 5AP)
MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )
PRODUCT CHARACTERISTICS
COLOR
white
S CORE
no sco re
S HAP E
ROUND
S IZ E
11mm
FLAVOR
IMPRINT CODE
PH0 46
CONTAINS
PACKAG ING
MARKETING START
MARKETING END
Preferred Pharmaceuticals Inc.
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ITEM CODE
PACKAGE DESC