SOOTHE CHILDRENS- 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, CARBONATE ION - UNII:7UJQ5OPE7D)
Available from:
Walgreen Company
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antacid relieves: - heartburn - acid indigestion - sour stomach - upset stomach associated with these symptoms
Authorization status:
OTC monograph final
Authorization number:
0363-5960-08

SOOTHE CHILDRENS- calcium carbonate tablet, chewable

Walgreen Company

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.

----------

Walgreens 44-596A

Active ingredient (in each chewable tablet)

Calcium carbonate 400 mg

Purpose

Antacid

Uses

relieves:

heartburn

acid indigestion

sour stomach

upset stomach associated with these symptoms

Warnings

Ask a doctor or pharmacist before use if the child is

presently taking a prescription drug. Antacids may interact with certain prescription drugs.

Stop use and ask a doctor if

symptoms last more than two weeks.

Keep this and all drugs out of the reach of children.

Directions

find the right dose on chart below based on weight (preferred); otherwise use age

chew or crush tablets completely before swallowing; do not swallow tablets whole

repeat dose as needed

do not take more than 3 chewable tablets (ages 2-5) or 6 chewable tablets (ages 6-11) in a 24-hour

period, or use the maximum dosage of this product for more than two weeks, except under the

advice and supervision of a doctor

Dosing Chart

Weight (lb)

Age (yr)

Dose (chewable tablets)

under 24

under 2

ask a doctor

24-47

1 tablet

48-95

6-11

2 tablets

Other information

each tablet contains: calcium 160 mg

store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

avoid excessive humidity

see end flap for expiration date and lot number

Inactive ingredients

acacia, corn starch, D&C red #27 aluminum lake, D&C red #30 aluminum lake, FD&C red #40 aluminum

lake, flavor, magnesium stearate, maltodextrin, silicon dioxide, sodium lauryl sulfate, sucrose, talc

Questions or comments?

1-800-426-9391

Principal Display Panel

Walgreens

Compare to Pepto® Kids

Chewables active ingredient

NDC 0363-5960-08

children's

Soothe®

CALCIUM CARBONATE 400 mg

CHEWABLE TABLETS / ANTACID

Relieves heartburn, sour stomach

& acid indigestion

24 CHEWABLE

TABLETS

Chew or crush tablets

completely before swallowing.

Do not swallow tablets whole.

BUBBLE GUM

FLAVOR

ACTUAL SIZE

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Walgreens

PHARMACIST

RECOMMENDED

Health expertise

you rely on,

quality you trust.

Walgreens Pharmacist Survey

††

††

This product is not manufactured or distributed by The

Procter & Gamble Company, owner of the registered

trademark Pepto® Kids Chewables. 50844 REV0119A59608

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

walgreens.com ©2018 Walgreen Co.

Walg reens 4 4 -596A

SOOTHE CHILDRENS

calcium carbonate tablet, chewable

††

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 36 3-59 6 0

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) (CALCIUM CATION - UNII:2M8 3C4R6 ZB,

CARBONATE ION - UNII:7UJQ5OPE7D)

CALCIUM

CARBONATE

40 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

ACACIA (UNII: 5C540 3N26 O)

D&C RED NO . 2 7 ALUMINUM LAKE (UNII: ZK6 4F7XSTX)

D&C RED NO . 3 0 (UNII: 2S42T28 0 8 B)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

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

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

TALC (UNII: 7SEV7J4R1U)

SUCRO SE (UNII: C151H8 M554)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

MALTO DEXTRIN (UNII: 7CVR7L4A2D)

STARCH, CO RN (UNII: O8 232NY3SJ)

Product Characteristics

Color

PINK

S core

no sco re

S hap e

ROUND

S iz e

16 mm

Flavor

BUBBLE GUM

Imprint Code

44;59 6

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 36 3-59 6 0 -0 8

1 in 1 CARTON

0 4/0 7/20 11

1

24 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH FINAL

pa rt331

0 4/0 7/20 11

Labeler -

Walgreen Company (008965063)

Walgreen Company

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 9 4

MANUFACTURE(0 36 3-59 6 0 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

0 38 15446 4

PACK(0 36 3-59 6 0 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 37

PACK(0 36 3-59 6 0 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

9 6 76 26 30 5

PACK(0 36 3-59 6 0 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 6 8 7340 8 8

PACK(0 36 3-59 6 0 )

Revised: 8/2020

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