Childrens Stomach Relief Antacid 657

Childrens Stomach Relief Antacid 657
SPL v2
SPL
SPL Set ID 18fae1aa-1001-8035-e063-6394a90adc66
Route
ORAL
Published
Effective Date 2025-01-14
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 2025-01-13

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 more 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, xanthagum.

Questions Or Comments?

1-(609) 860-2600 Mon.- Fri. 8:00 am - 4:30 pm.

Principal Display Panel

Compare to Kid's pepto® active ingredient*

NDC 37808-638-03

H E B

Children's 

Stomach Relief

Calcium Carbonate 400 mg / 5 mL

Antacid

Relief of :



  • Acid Indigestion
  • Heartburn
  • Sour Stomach
  • Upset Stomach


Orange Creme Flavor 



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 more 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, xanthagum.

Questions Or Comments? (Questions or comments?)

1-(609) 860-2600 Mon.- Fri. 8:00 am - 4:30 pm.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Compare to Kid's pepto® active ingredient*

NDC 37808-638-03

H E B

Children's 

Stomach Relief

Calcium Carbonate 400 mg / 5 mL

Antacid

Relief of :



  • Acid Indigestion
  • Heartburn
  • Sour Stomach
  • Upset Stomach


Orange Creme Flavor 



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

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