Infants Simethicone Drops
Infants Simethicone Drops is an FDA drug label for the active ingredient INFANTS SIMETHICONE DROPS manufactured by PAI Holdings, LLC dba PAI Pharma administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260603.
- Generic name
- INFANTS SIMETHICONE DROPS
- Manufacturer
- PAI Holdings, LLC dba PAI Pharma
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 0121-1094
- Application
- M002
- Label effective
- 20260603
About this product
Infants Simethicone Drops is an FDA-registered drug product whose active ingredient is INFANTS SIMETHICONE DROPS. It is labelled by PAI Holdings, LLC dba PAI Pharma taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 0121-1094, application M002, label effective 20260603. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.
What it is used for
Across FDA labelling, products containing INFANTS SIMETHICONE DROPS are most often described in connection with: symptoms referred. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Use relieves the symptoms referred to as gas
Dosage & Administration
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 use other syringe, dropper, spoon or dosing device when giving this medicine to a child 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 mL = milliliter Age (years) Weight (lbs) Dose infants (under 2) under 24 0.3 mL
Warnings
Warnings Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.
Frequently asked questions
What is Infants Simethicone Drops used for?
Use relieves the symptoms referred to as gas
Who makes Infants Simethicone Drops?
PAI Holdings, LLC dba PAI Pharma is the labeler of record for Infants Simethicone Drops.
What form does Infants Simethicone Drops come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.
Is Infants Simethicone Drops prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.
Has Infants Simethicone Drops been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.
Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.