Dolgencorp, LLC Antacid Chews Drug Facts

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:

Dolgencorp, LLC

INN (International Name):

CALCIUM CARBONATE

Composition:

CALCIUM CARBONATE 750 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antacid relieves

Authorization status:

OTC monograph final

Summary of Product characteristics

REXALL ANTACID- CALCIUM CARBONATE TABLET, CHEWABLE
DOLGENCORP, LLC
_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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DOLGENCORP, LLC ANTACID CHEWS DRUG FACTS
ACTIVE INGREDIENT (IN EACH TABLET)
Calcium carbonate USP 750mg
PURPOS E
Antacid
US ES
relieves
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WARNINGS
ASK A DOCTOR BEFORE USE IF YOU HAVE
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ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
WHEN USING THIS PRODUCT
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KEEP OUT OF REACH OF CHILDREN.
DIRECTIONS
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heartburn
sour stomach
acid indigestion
upset stomach associated with these symptoms
kidney stones
a calcium-restricted diet
presently taking a prescription drug. Antacids may interact with
certain prescription drugs.
do not take more than 10 tablets in 24 hours
if pregnant do not take more than 6 tablets in 24 hours
do not use the maximum dosage for more than 2 weeks except under the
advice and supervision of
a doctor
adults and children 12 years of age and over: chew 2 - 4 tablets as
symptoms occur, or as directed
by a doctor
do not take for symptoms that persist for more than 2 weeks unless
advised by a doctor
OTHER INFORMATION
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INACTIVE INGREDIENTS
dextrose, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake,
flavors, glycerin, magnesium
stearate, maltodextrin, mineral oil
PRINCIPAL DISPLAY PANEL
EXTRA STRENGTH
Antacid Chews
Calcium Carbonate 750 mg
Assorted Berries Flavors
750 mg
200 Chewable Tablets
each tablet contains: calcium 320mg
store at 20-25°C (68-77°F)
does not meet USP for assay
REXALL ANTACID
calcium carbonate tablet, chewable
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:559 10 -70 8
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
750 mg
Dolgencorp, LL