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 Cvs. 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 5 Ml)
Calcium carbonate 400 mg
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.
Principal Display Panel
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)
* Please review the disclaimer below.
