EXTRA STRENGTH SUGAR FREE ORANGE CREAM FLAVOR- calcium carbonate tablet, chewable

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:
Raritan Pharmaceuticals Inc
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antacid relieves
Authorization status:
OTC monograph final
Authorization number:
68163-202-90

EXTRA STRENGTH SUGAR FREE ORANGE CREAM FLAVOR- calcium carbonate tablet,

chewable

Raritan 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.

----------

Extra Strength SUGAR FREE Antacid Tablets Calcium Carbonate 750 mg

Active ingredient (per tablet)

Calcium Carbonate USP 750 mg

Purpos e

Antacid

Us es

relieves

Warnings

Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may

interact with certain prescription drugs.

When using this product

Keep out of reach of children.

Directions

Other Information

heartburn

acid indigestion

sour stomach

upset stomach associated with these symptoms

do not take more than 9 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

each tablet contains: elemental calcium 300 mg

Inactive ingredients

adipic acid, flavors, magnesium stearate, maltodextrin, sorbitol, starch, sucralose, FD&C Yellow No. 6

lake.

Questions or comments?

1-866-467-2748

SAFETY SEALED: DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

Package/Label Principal Display Panel

NDC 68163-202-90

DRxCHOICE

Compare to Tums® active ingredient*

EXTRA STRENGTH

Antacid

Tablets

Calcium Carbonate USP 750 mg

Sugar-Free

90 CHEWABLE TABLETS

K PARVE

Distributed by:

Raritan Pharmaceuticals

8 Joanna Court, East Brunswick, NJ 08816

*This product is not manufactured or distributed by GlaxoSmithKline LLC, owner of the registered

trademark, TUMS .

store below 30°C (86°F).

Relieves:

Acid Indigestion

Sour Stomach

Heartburn

Orange Cream Flavor

Naturally and Artificially Flavored

GLUTEN FREE

EXTRA STRENGTH SUGAR FREE ORANGE CREAM FLAVOR

calcium carbonate tablet, chewable

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 8 16 3-20 2

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

Raritan Pharmaceuticals Inc

Inactive Ingredients

Ingredient Name

Stre ng th

ADIPIC ACID (UNII: 76 A0 JE0 FKJ)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

MALTO DEXTRIN (UNII: 7CVR7L4A2D)

SO RBITO L (UNII: 50 6 T6 0 A25R)

STARCH, CO RN (UNII: O8 232NY3SJ)

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )

Product Characteristics

Color

ORANGE

S core

no sco re

S hap e

ROUND

S iz e

16 mm

Flavor

ORANGE (Cream)

Imprint Code

RP10 2SF

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 8 16 3-20 2-

9 0 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 4/18 /20 19

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

0 4/18 /20 19

Labeler -

Raritan Pharmaceuticals Inc (127602287)

Revised: 8/2020

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