Active Ingredient (In Each 5 Ml)
Calcium carbonate 400 mg
Childrens Antacid Liquid
FDA Label NDC 51316-657
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs for the product Childrens Antacid (NDC 51316-657). 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 5 ml), purpose, use(s), warnings, ask a doctor or pharmacist before use if the child is, stop use and ask doctor if, keep this and all drugs out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antacid
Use(S)
relieves:
- acid indigestion
- heartburn
- sour stomach
- upset stomach associated with these symptoms
Warnings
Do not take nore than 15 mL (age 2-5 yrs) or 30 mL (age 6-11 yrs) in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.
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 Doctor If
symptoms lasts more than two weeks
Keep This And All Drugs Out Of Reach Of Children
.
Directions
- shake well before use
- find the right dose on the chart below based on weight (preferred), otherwise use age.
- repeat dose as needed
- dosing cup provided
- mL=milliliter
Dosing Chart
| Weight (lbs.) | Age | Dose |
| under 24 | under 2 yrs. | ask a doctor |
| 24-47 | 2-5 yrs. | 5 mL |
| 48-95 | 6-11 yrs. | 10 mL |
Other Information
- each 5 mL contains: calcium 161 mg
- store at controlled room temperature 20-25°C (68°F-77°F)
Inactive Ingredients
benzyl alcohol, D&C yellow#10 dye, FD&C red#40 dye, flavors, glycerin, hydroxyethyl cellulose, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sorbitol, sucralose, xanthan gum.
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CVS
Health.
Compare to the active ingredient in pepto® kids*
Orange Cream
NDC 51316-657-03
Children's
Antacid Liquid
CALCIUM CARBONATE 400 mg
RELIEVES :
- Acid indigestion & heartburn
- Sour & upset Stomach due to these symptoms
Orange Cream
4 FL OZ (118 mL)
657-4-cvs.jpg (657 4 Cvs)
* Please review the disclaimer below.
