Active Ingredient (In Each 0.3 Ml)
Simethicone 20 mg
Simethicone
FDA Label NDC 54868-5620
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Physicians Total Care, Inc. for the product Simethicone (NDC 54868-5620). 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), purpose, uses, 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 discomfort of infant gas frequently caused by air swallowing or certain formulas or foods.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- shake well before using
- all dosages may be repeated as needed, after meals and at bedtime or as directed by a physician. Do not exceed 12 doses per day.
- fill enclosed dropper to recommended dosage level and dispense liquid slowly into baby’s mouth, toward the inner cheek
- dosage can also be mixed with 1 oz of cool water, infant formula or other suitable liquids
- for best results, clean dropper after each use and replace original cap
| Age | Weight | Dose |
| newborn | - - - - | 0.3 mL |
| infants under 2 years | under 24 lbs | 0.3 mL |
| children over 2 years | over 24 lbs | 0.6 mL |
Other Information
- store at room temperature 15°- 30°C (59°- 86°F)
- do not freeze
You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.
Inactive Ingredients
carbomer, citric acid, FD&C red #3, flavor, hypromellose, purified water, saccharin sodium, sodium benzoate, sodium citrate
* Please review the disclaimer below.
