Active Ingredient(In Each Tablet)
Calcium carbonate 400 mg
Soothe Tablet, Chewable
FDA Label NDC 0363-5960
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Company for the product Soothe (NDC 0363-5960). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient(in each tablet), purpose, uses, ask a doctor or pharmacist before use if the child is, stop use and ask a doctor if, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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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