Home DailyMed 5a6d2c1f-4067-969f-e063-6394a90aa83f Simethicone (ENFIT) Oral Suspension, USP Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer Everpharm LLC
Effective date 2026-09-02
Label type HUMAN OTC DRUG LABEL
Version 2
Source daily-update
Hydrated at 2026-09-05 01:01:09 Label at a glance# Product Simethicone Drops
Active ingredient DIMETHICONE
Label structure 10 sections
Dosage and administration 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
Product Linked Resources# Resource, Code type, Value table Resource Code type Value Equivalent identifiers Source image Barcode EAN-13 0384415003017 GTIN-13: 0384415003017EAN-13: 0384415003017GTIN-12: 384415003017UPC-A: 384415003017GTIN storage (14 digits): 00384415003017simethiconepdp.jpg
Products# Every source-derived product name is available through these pages.
DailyMed product names page 1 of 1 · 10 matching rows.
Simethicone Drops DIMETHICONE CARBOXYMETHYLCELLULOSE SODIUM ANHYDROUS CITRIC ACID MALTITOL MICROCRYSTALLINE CELLULOSE WATER SODIUM BENZOATE SODIUM CITRATE XANTHAN GUM Ingredients# Every source-derived ingredient row is available through these pages.
DailyMed ingredient rows page 1 of 1 · 9 matching rows.
Older Hydrated Versions# Version, Effective date, Source table Version Effective date Source Hydrated 1 2026-09-01 daily-update 2026-09-03 03:02:06
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.