Quality Choice 44-596a

Quality Choice 44-596a
SPL v3
SPL
SPL Set ID fb47d693-72d7-4586-9855-5e833ad1406f
Route
ORAL
Published
Effective Date 2025-03-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Carbonate Ion (400 mg)
Inactive Ingredients
Acacia Starch, Corn D&c Red No. 27 Aluminum Lake D&c Red No. 30 Aluminum Lake Fd&c Red No. 40 Aluminum Lake Magnesium Stearate Maltodextrin Silicon Dioxide Sodium Lauryl Sulfate Sucrose Talc

Identifiers & Packaging

Pill Appearance
Imprint: 44;596 Shape: round Color: pink Size: 16 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-13

Description

Calcium carbonate 400 mg

Purpose

Antacid


Medication Information

Purpose

Antacid

Description

Calcium carbonate 400 mg

Uses

relieves:

  • heartburn
  • acid indigestion
  • sour stomach
  • upset stomach associated with these symptoms
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

Questions Or Comments?
1-800-426-9391
Principal Display Panel

Quality Choice®

NDC 83324-225-24

*Compare to the

Active Ingredient in

Pepto® Kids Chewables

Children’s

Stomach Relief

Calcium Carbonate 400 mg Chewable Tablets

Antacid

Relieves Acid Indigestion, Heartburn,

Sour Stomach, Upset Stomach

24 Chewable Tablets 

Actual Size

Bubblegum

Flavor

Chew or crush tablets

completely before swallowing.

TAMPER EVIDENT: DO NOT USE IF

IMPRINTED SAFETY SEAL UNDER

CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by

The Procter & Gamble Company, owner of the

registered trademark Pepto® Kids Chewables.

Distributed by CDMA, Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

Quality choice 44-596A
Stop Use and Ask A Doctor If

symptoms last more than two weeks.

Active Ingredient (in Each Chewable Tablet)

Calcium carbonate 400 mg

Ask A Doctor Or Pharmacist Before Use If the Child Is

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

Keep This and All Drugs Out of the Reach of Children.



Structured Label Content

Uses

relieves:

  • heartburn
  • acid indigestion
  • sour stomach
  • upset stomach associated with these symptoms
Purpose

Antacid

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 (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 (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? (Questions or comments?)
1-800-426-9391
Principal Display Panel

Quality Choice®

NDC 83324-225-24

*Compare to the

Active Ingredient in

Pepto® Kids Chewables

Children’s

Stomach Relief

Calcium Carbonate 400 mg Chewable Tablets

Antacid

Relieves Acid Indigestion, Heartburn,

Sour Stomach, Upset Stomach

24 Chewable Tablets 

Actual Size

Bubblegum

Flavor

Chew or crush tablets

completely before swallowing.

TAMPER EVIDENT: DO NOT USE IF

IMPRINTED SAFETY SEAL UNDER

CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by

The Procter & Gamble Company, owner of the

registered trademark Pepto® Kids Chewables.

Distributed by CDMA, Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

Quality choice 44-596A
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

symptoms last more than two weeks.

Active Ingredient (in Each Chewable Tablet) (Active ingredient (in each chewable tablet))

Calcium carbonate 400 mg

Ask A Doctor Or Pharmacist Before Use If the Child Is (Ask a doctor or pharmacist before use if the child is)

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

Keep This and All Drugs Out of the Reach of Children. (Keep this and all drugs out of the reach of children.)



Advanced Ingredient Data


Raw Label Data

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