Active Ingredient (In Each 0.6 Ml Unit-Dose Syringe)
Simethicone 40 mg
Simethicone Drops Liquid
FDA Label NDC 84415-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Everpharm Llc for the product Simethicone Drops (NDC 84415-003). 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 0.6 ml unit-dose 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 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
| Age (years) | Weight (lbs) | Dose |
| children (age 2 and over) | 24 and over | 0.6 mL |
Other Information
- TAMPER-EVIDENT: Do not use if wrapper containing syringe is torn or open
- store at room temperature 20°-25°C (68°-77°F)
- do not freeze
Inactive Ingredients
carboxymethylcellulose sodium, citric acid, flavor, maltitol, microcrystalline cellulose, purified water, sodium benzoate, sodium citrate, xanthan gum
Questions Or Comments?
1-866-838-3774
Principal Display Panel
NDC 84415-003-01
Simethicone (ENFIT)
Oral Suspension, USP
40 mg/0.6 mL
Distributed by:
Everpharm LLC
Marlborough MA 01752
50 UNITS x 0.6 mL
Pdp (Simethiconepdp)
* Please review the disclaimer below.
