Active Ingredient (In Each 0.3 Ml Filled Syringe)
Simethicone 20 mg
Infants Simethicone Drops Liquid
FDA Label NDC 0121-1094
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pai Holdings, Llc Dba Pai Pharma for the product Infants Simethicone Drops (NDC 0121-1094). 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 0.3 ml filled syringe), purpose, use, keep out of reach of children., directions, other information, inactive ingredients, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antigas
Use
relieves the symptoms referred to as gas
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a poison control center right away.
Directions
- dose may be repeated as needed, after meals and at bedtime, or as directed by a physician
- only use the unit dose filled syringe. Do not use other syringe, dropper, spoon or dosing device when giving this medicine to a child
- do not exceed 12 doses per day
- dosage can also be mixed with 1 oz. of cool water, infant formula or other suitable liquids
- discard syringe after use
- mL = milliliter
| Age (years) | Weight (lbs) | Dose |
| infants (under 2) | under 24 | 0.3 mL |
Other Information
- store at room temperature 15°-30°C (59°-86°F)
- protect from freezing
- do not use if wrapper containing syringe is torn or open
Inactive Ingredients
carboxymethylcellulose sodium, citric acid, flavor, maltitol, microcrystalline cellulose, purified water, sodium benzoate, sodium citrate, xanthan gum
Questions Or Comments?
1-800-845-8210
Principal Display Panel
NDC 0121-1094-03
Compare to the
ingredient of
infants MYLICON®*
Infants'
Simethicone Drops
DYE FREE
20 mg/0.3 mL
Antigas
Relieves the Symptoms
Referred to as Gas
PAI Pharma
Each Box Contains
25 x 0.3 mL (0.01010 fl oz) Unit Dose Filled Syringes
Carton For Infants Simethicone Drops (Infsimdrps 1) 
* Please review the disclaimer below.
