STOMACH RELIEF CHILDRENS- 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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Rexall 44-596 Delisted

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	2-5	1 tablet
48-95	6-11	2 tablets

Other information

each tablet contains: calcium 160 mg
store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
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

Principal Display Panel

Children's

Since 1903
Rexall®

Stomach Relief
Calcium carbonate 400 mg chewable Tablets / Antacid

24 Tablets

Relief of
• Heartburn
• Acid indigestion
• Upset stomach

Bubble Gum Flavor

Chew or crush tablets completely before swallowing.

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

Visit us at: Rexall.com
or call 1-866-4-REXALL

MANUFACTURED FOR DOLGENCORP, LLC
100 MISSION RIDGE
GOODLETTSVILLE, TN 37072 USA

Since 1903 Rexall® is a registered
trademark of Rexall Sundown, Inc.

50844 REV0119A59608

Rexall 44-596A

STOMACH RELIEF CHILDRENS
calcium carbonate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55910-596
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D, CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CARBONATE	400 mg

Ingredient Name	Strength
Inactive Ingredients
ACACIA (UNII: 5C5403N26O)
STARCH, CORN (UNII: O8232NY3SJ)
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)
D&C RED NO. 30 (UNII: 2S42T2808B)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	pink	Score	no score
Shape	ROUND	Size	16mm
Flavor	BUBBLE GUM	Imprint Code	44;596
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55910-596-08	1 in 1 CARTON	08/01/2018	03/10/2022
1		24 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part331	08/01/2018	03/10/2022

Labeler - DOLGENCORP, LLC (068331990)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(55910-596)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	manufacture(55910-596)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(55910-596)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		117025878	manufacture(55910-596)

Revised: 9/2022

Document Id: cee97a16-e37a-46e6-8c71-852c9df217bc

Set id: 3888a861-26b1-4ded-a09b-ae8ddfedb359

Version: 12

Effective Time: 20220923

DOLGENCORP, LLC