CALCIUM CARBONATE (ANTACID)- calcium carbonate tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D, CALCIUM CATION - UNII:2M83C4R6ZB)
Available from:
Pharbest 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 - acid indigestion - heartburn - sour stomach - upset stomach associated with these symptoms
Authorization status:
OTC monograph final
Authorization number:
16103-377-08, 16103-377-11

CALCIUM CARBONATE (ANTACID)- calcium carbonate tablet

Pharbest 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

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 15 to 30 c (59 to 86 F)

use by expiration date on package

Inactive ingredients

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: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

CELLULO SE, MICRO CRYSTALLINE (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

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:16 10 3-377-0 8

10 0 in 1 BOTTLE, PLASTIC

2

NDC:16 10 3-377-11

10 0 0 in 1 BOTTLE, PLASTIC

Pharbest Pharmaceuticals Inc.

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt331

11/29 /20 0 6

Labeler -

Pharbest Pharmaceuticals Inc. (557054835)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Pharbest Pharmaceuticals Inc.

5570 548 35

manufacture(16 10 3-377) , pack(16 10 3-377) , label(16 10 3-377)

Revised: 4/2013

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