Active Ingredient (In Each Chewable Tablet)
Calcium carbonate 400 mg
Childrens Stomach Relief Tablet, Chewable
FDA Label NDC 83324-225
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association, Inc. for the product Childrens Stomach Relief (NDC 83324-225). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each chewable tablet), purpose, uses, ask a doctor or pharmacist before use if the child is, stop use and ask a doctor if, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antacid
Uses
relieves:
- heartburn
- acid indigestion
- sour stomach
- upset stomach associated with these symptoms
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.
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 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
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 (Quality Choice 44 596a 1)
* Please review the disclaimer below.
