REGULAR STRENGTH ANTACID ASSORTED FRUIT- calcium carbonate tablet, chewable

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

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Active ingredient:
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)
Available from:
CARDINAL HEALTH
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antacid relieves:
Authorization status:
OTC monograph final
Authorization number:
70000-0034-1

REGULAR STRENGTH ANTACID ASSORTED FRUIT- calcium carbonate tablet, chewable

CARDINAL HEALTH

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.

----------

Regular Strength Antacid Tablets Assorted Fruit Flavor

Active ingredient

Calcium Carbonate USP 500mg

Purpos e

Antacid

Us es

relieves:

Warnings

Ask a doctor or pharmacist before use if you are 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

sour stomach

acid indigestion

upset stomach associated with these symptoms

do not take more than 15 tablets in 24 hours

if pregnant do not take more than 10 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 completely as symptoms occur,

or as directed by a doctor. Do not swallow tablets whole.

Do not take for symptoms that persist for more than 2 weeks unless advised by a doctor.

each tablets contains: elemental calcium 200mg

Store at room temperature. Keep the container tightly closed

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

Inactive ingredients

adipic acid, D&C Red No. 27, D&C Yellow No. 10, dextrose, FD&C Blue No. 1, flavors, magnesium

stearate, maltodextrin, starch, sucralose.

Package/Label Principal Display Panel

NDC 70000-0034-1

COMPARE TO TUMS® REGULAR STRENGTH active ingredient*

Regular Strength

Antacid Tablets

Calcium Carbonate 500mg

Assorted Fruit Flavor

Naturally and Artificially Flavored

Relieves:

Upset Stomach

Heartburn

Acid Indigestion

100% Money Back Guarantee

150 Chewable Tablets

©2019 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO,

LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinals Health.

All other marks are the property of their respective owners.

www.myleader.com

DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017

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

trademark, Tums

Regular Strength.

Cardinal Reg ular Streng th Antacid Tablets

REGULAR STRENGTH ANTACID ASSORTED FRUIT

calcium carbonate tablet, chewable

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:70 0 0 0 -0 0 34

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

CALCIUM CARBO NATE (UNII: H0 G9 379 FGK) (CALCIUM CATION - UNII:2M8 3C4R6 ZB)

CALCIUM CARBONATE

50 0 mg

CARDINAL HEALTH

Inactive Ingredients

Ingredient Name

Stre ng th

ADIPIC ACID (UNII: 76 A0 JE0 FKJ)

D&C RED NO . 2 7 (UNII: 2LRS18 5U6 K)

D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)

DEXTRO SE, UNSPECIFIED FO RM (UNII: IY9 XDZ35W2)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

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

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

MALTO DEXTRIN (UNII: 7CVR7L4A2D)

STARCH, CO RN (UNII: O8 232NY3SJ)

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

Product Characteristics

Color

RED, YELLOW, ORANGE, GREEN

S core

no sco re

S hap e

ROUND

S iz e

16 mm

Flavor

FRUIT (Asso rted)

Imprint Code

RP10 1

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:70 0 0 0 -0 0 34-

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

Pro duc t

0 4/16 /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 4/16 /20 19

Labeler -

CARDINAL HEALT H (097537435)

Revised: 4/2019

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