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

Description

Calcium carbonate 400 mg

Purpose

Antacid


Medication Information

Purpose

Antacid

Description

Calcium carbonate 400 mg

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.

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.

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)





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

Use(s) (USE(S))

relieves:

  • acid indigestion
  • heartburn
  • sour stomach
  • upset stomach associated with these symptoms
Purpose (PURPOSE)

Antacid

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.

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)





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)