Start a conversation
Home/Communities/Simethicone Drops
Si

OTC products · Product label record

Simethicone Drops drug information

SIMETHICONE DROPS
Everpharm LLC · ORAL

Product NDC: 84415-003

Join the community
CommunityExperiencesReviewsDrug database
Source label information, not individualized medical advice. This record applies to the product and labeler shown below. Compare the exact formulation, strength and country with your package and the current source label.
Generic nameSIMETHICONE DROPS
Labeler / manufacturerEverpharm LLC
RouteORAL
Drug classDrug class not supplied in source label
Product NDC84415-003
Label effective date2026-09-02

Official product label reference

Simethicone Drops — Everpharm LLC

This page contains 9 source sections for SIMETHICONE DROPS, oral route. Label set 5a6d2c1f-4067-969f-e063-6394a90aa83f, version 2.

Retrieved 2026-10-02 · openFDA dataset updated 2026-10-02 · Check the current DailyMed label

Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.

Uses described in the label

Use relieves the symptoms referred to as gas

Purpose

Purpose Antigas
Dosage and administration — label text
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 Table text from source: | Age (years) | Weight (lbs) | Dose | children (age 2 and over) | 24 and over | 0.6 mL
Warnings
Warnings Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.
Unclassified section
Drug Facts Other information TAMPER-EVIDENT: Do not use if wrapper containing syringe is torn or open store at room temperature 20º-25ºC (68º-77ºF) do not freeze
Active ingredient
Active ingredient (in each 0.6 mL unit-dose syringe) Simethicone 40 mg
Child safety
Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.
Inactive ingredient
Inactive ingredients carboxymethylcellulose sodium, citric acid, flavor, maltitol, microcrystalline cellulose, purified water, sodium benzoate, sodium citrate, xanthan gum
Questions
Questions or comments? 1-866-838-3774

Official sources and product identifiers

Substances listed: DIMETHICONE

RxNorm identifiers: 198857

Package NDC codes

84415-003-01

Further research and background

These are external searches for related information. Research, encyclopedia and news articles have not been imported into this product record.

Coverage and corrections

The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.

Source retrieved 2026-10-02. Read the source policy.