childrens antacid liquid

childrens antacid liquid
SPL v2
SPL
SPL Set ID 1bf90c0c-b639-1c06-e063-6394a90ab85b
Route
oral
Published
Effective Date 2025-01-16
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
calcium cation (400 mg)
Inactive Ingredients
d&c yellow no. 10 benzyl alcohol fd&c red no. 40 glycerin hydroxyethyl cellulose (2000 mpa.s at 1%) methylparaben propylparaben propylene glycol water sodium citrate sorbitol sucralose xanthan gum

Identifiers & Packaging

Pill Appearance
Color: orange
Marketing Status
otc monograph drug active Since 2025-01-15

Purpose

Antacid

Description

Calcium carbonate 400 mg


Medication Information

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.

Purpose

Antacid

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 20-25ºC (68ºF-77ºF)
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.

Description

Calcium carbonate 400 mg

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)





Use(s)

relieves:

  • acid indigestion
  • heartburn
  • sour stomach
  • upset stomach associated with these symptoms
Stop Use and Ask Doctor If

symptoms lasts more than two weeks

Active Ingredient (in Each 5 Ml)

Calcium carbonate 400 mg

Keep This and All Drugs Out of Reach of Children

.

Ask A Doctor Or Pharmacist Before Use If the Child Is
  • presently taking a prescription drug. Antacids may interact with certain prescription drugs.

Structured Label Content

Warnings (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.

Purpose (PURPOSE)

Antacid

Directions (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 (OTHER INFORMATION)
  • each 5 mL contains: calcium 161 mg
  • store at controlled room temperature 20-25ºC (68ºF-77ºF)
Inactive Ingredients (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 (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)





Use(s) (USE(S))

relieves:

  • acid indigestion
  • heartburn
  • sour stomach
  • upset stomach associated with these symptoms
Stop Use and Ask Doctor If (STOP USE AND ASK DOCTOR IF)

symptoms lasts more than two weeks

Active Ingredient (in Each 5 Ml) (ACTIVE INGREDIENT (in each 5 mL))

Calcium carbonate 400 mg

Keep This and All Drugs Out of Reach of Children (KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN)

.

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.

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)