OTC Medication Information: Soothe Childrens

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.

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(chewabletablets)
under 24 under 2 ask a doctor
24-47 2-5 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

• WALGREENS •
PHARMACIST RECOMMENDED†

Compare to the active ingredient in
Pepto® Kids Chewables ††

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

Our pharmacists recommend the
Walgreens brand. We invite you to
compare to national brands.
†† This product is not manufactured or distributed by The
Procter & Gamble Company, owner of the registered
trademark Pepto® Kids Chewables. 50844 ORG111959608

TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED walgreens.com ©2021 Walgreen Co.

Walgreens 44-596A
(click image for full-size original)

Walgreens 44-596A

SOOTHE CHILDRENS calcium carbonate tablet, chewable
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-5960
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCIUM CARBONATE (CALCIUM CATION and CARBONATE ION) CALCIUM CARBONATE 400 mg
Inactive Ingredients
Ingredient Name Strength
ACACIA
STARCH, CORN
D&C RED NO. 27 ALUMINUM LAKE
D&C RED NO. 30
FD&C RED NO. 40
MAGNESIUM STEARATE
MALTODEXTRIN
SILICON DIOXIDE
SODIUM LAURYL SULFATE
SUCROSE
TALC
Product Characteristics
Color pink Score no score
Shape ROUND Size 16mm
Flavor BUBBLE GUM Imprint Code 44;596
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-5960-08 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 24 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC This package is contained within the CARTON (0363-5960-08)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part331 08/01/2018
Labeler — Walgreen Company (008965063)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 038154464 pack (0363-5960)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867837 manufacture (0363-5960)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 967626305 pack (0363-5960)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 117025878 manufacture (0363-5960)

Revised: 01/2023 Walgreen Company

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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