FDA Label for Pediacare Gas Relief Drops Dye Free
View Indications, Usage & Precautions
Pediacare Gas Relief Drops Dye Free Product Label
The following document was submitted to the FDA by the labeler of this product Medtech Products Inc.. 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 0.3 mL)
Simethicone Emulsion USP 66.7mg/Simethicone 20 mg
Purpose
Anti-Gas
Uses
relieves the symptoms of gas frequently caused by air swallowing or certain formulas or foods
When Using This Product
do not exceed 12 doses per day
Keep Out Of Reach Of Children.
In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.
Directions
- shake well before using
- all dosages may be repeated as needed, after meals and at bedtime
- fill enclosed dropper to recommended dosage level
- dispense liquid slowly into baby’s mouth, toward inner cheek
- may mix with 1 oz. of cool water, infant formula or other suitable liquids
- clean dropper after each use and replace original cap
Dose by weight or if weight information is not available, dose by age.
| age (yr) | weight (lb) | dose |
| infants under 2 | under 24 | 0.3 mL |
| children 2 and over | 24 and over | 0.6 mL |
Other Information
- Do not freeze
- Store at room temperature 20-25°C (68-77°F)
- See bottle or box for lot number and expiration date
Inactive Ingredients
citric acid, flavor, microcrystalline cellulose, propylene glycol, sodium benzoate, sodium carboxymethylcellulose, sucralose, xanthan gum
Questions Or Comments?
call 1-888-474-3099 Mon. – Fri. 8 am to 8 pm EST or visit us at PediaCare.com
Principal Display Panel
INFANTS 0-36 months
PediaCare® we care for kidsTM
Gas Relief DROPS
SIMETHICONE-ANTI GAS
NON-STAINING
1 FL OZ (30 mL)
* Please review the disclaimer below.