Active Ingredient
(in each 0.3 mL)
Simethicone Emulsion USP 66.7mg/Simethicone 20 mg
Pediacare Gas Relief Drops Dye Free
FDA Label NDC 63029-811
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Medtech Products Inc. for the product Pediacare Gas Relief Drops Dye Free (NDC 63029-811). 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, purpose, uses, when using this product, keep out of reach of children., 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
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)
Principal Display Panelinfants 0-36 Monthspediacare® We Care For Kidstmgas Relief Dropssimethicone-anti Gasnon-staining1 Fl Oz (30 mL) (Pediacare Gas Relief Drops Dye Free 01)
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