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 the inner cheek may mix with 1 oz. of cool water, infant formula or other suitable liquids clean dropper after each use and close the bottle to maintain child resistance age (yr) weight (lb) dose infants under 2 under 24 0.3...
store at room temperature
Simethicone 20 mg
Antigas
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
In case of overdose, get medical help or contact a Poison Control Center right away
| age (yr) | weight (lb) | dose |
| infants under 2 | under 24 | 0.3 mL |
| children over 2 | over 24 | 0.6 mL |
store at room temperature
benzoic acid, flavor, magnesium aluminum silicate, purified water, simethicone emulsion, sorbitol, xanthan gum
Topcare health
COMPARE TO MYLICON® NON-STAINING INFANTS' DROPS ACTIVE INGREDIENT*
NDC 36800-119-09
NON-STAINING
DYE-FREE
infants'
Gas Relief
Drops
SIMETHICONE 20 mg
ANTI-GAS
**use as directed
1 FL OZ (30 mL)
| Class | Version | Type | Effective |
|---|---|---|---|
| DIMETHICONE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 36800-119-09 | Infants Gas relief | 30 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 30 | 2 | |
| 36800-119-09 | Infants Gas relief | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 36800-119 | 36800-119-09 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DIMETHICONE | 92RU3N3Y1O | ACTIB |
| BENZOIC ACID | 8SKN0B0MIM | IACT |
| MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITOL | 506T60A25R | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Infants Gas relief | SIMETHICONE | Topco Associates, LLC | fd6a2537-8db2-492d-b045-6404df2fb9c3 | 2024-12-26 | Warnings | 36800-119-09 36800-119 36800011909 edbc1a70-0fe7-42c4-a835-140c9f6aaf4a fd6a2537-8db2-492d-b045-6404df2fb9c3 |
Adverse event summaries are temporarily unavailable. Other product information remains available.