FDA Label for Childrens Antacid
View Indications, Usage & Precautions
Childrens Antacid Product Label
The following document was submitted to the FDA by the labeler of this product Dolgencorp, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
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?
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Compare to active ingredient
of Pepto® Kids Chewables*
Children's
Antacid
Calcium Carbonate, 400 mg
Chewable Tablets/Antacid
Relieves
• Acid Indigestion
• Heartburn, Sour Stomach
• Upset Stomach
Chew or crush
tablets completely
before swallowing.
Bubble Gum
Flavor
24 Chewable
Tablets
Actual Tablet Size
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.
50844 ORG111959608
DISTRIBUTED BY
OLD EAST MAIN CO.
100 MISSION RIDGE
GOODLETTSVILLE, TN 37072
* Please review the disclaimer below.