FDA Label for Soothe Childrens
View Indications, Usage & Precautions
Soothe Childrens Product Label
The following document was submitted to the FDA by the labeler of this product Walgreen Company. 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 Tablet)
Calcium carbonate 400 mg
Purpose
Antacid
Uses
relieves:
- heartburn
- acid indigestion
- sour stomach
- upset stomach due to these symptoms or over overindulgence in food and drink
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 A Doctor If
symptoms last more than two weeks.
Directions
- find the right dose on chart below based on weight (preferred), otherwise use age
- repeat dose as needed
- do not take more than 3 tablets (ages 2-5) or 6 tablets (ages 6-11) in a 24-hour period, or use the maximum dosage of this product for more than two weeks, except under the advice and supervision of a doctor
Dosing Chart
Weight (lbs.) | Age | Dose |
under 24 | under 2 years | ask a doctor |
24-47 | 2-5 yrs | 1 tablet |
48-95 | 6-11 yrs | 2 tablets |
Other Information
- each tablet contains: calcium 160 mg
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- avoid excessive humidity
- see end flap for expiration date and lot number
Inactive Ingredients
acacia, corn starch, D&C red #27 aluminum lake, D&C red #30 aluminum lake, FD&C red #40 aluminum lake, flavor, magnesium stearate, maltodextrin, silicon dioxide, sodium lauryl sulfate, sucrose, talc
Questions Or Comments?
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Compare to Children's Pepto®
active ingredient††
NDC 0363-5960-08
children's
Soothe®
CALCIUM CARBONATE 400 mg / ANTACID
CHEWABLE
•Relieves heartburn, sour stomach
& acid indigestion
24 CHEWABLE
TABLETS
BUBBLE GUM FLAVOR
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
†Walgreens Pharmacist Survey
††This product is not manufactured or
distributed by Procter & Gamble,
owner of the registered trademark
Children's Pepto®.
50844 ORG021859608
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