TEENY TUMMY Gas Relief Drops

TEENY TUMMY Gas Relief Drops is an FDA-registered drug product whose active ingredient is SIMETHICONE. It is labelled by Akron Pharma taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 71399-0041, application M002, label effective 20260901. It is one of 57 FDA drug label records sharing the active ingredient SIMETHICONE. 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.

Across FDA labelling, products containing SIMETHICONE 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.

Uses relieves the symptoms referred to as gas

Directions • shake well before using • all dosages may be repeated as needed, after meals and at bedtime, or as directed by a physician • do not exceed 12 doses per day • fill enclosed dropper to recommended dosage level and dispense liquid slowly into baby’s mouth, toward the inner cheek • dosage can also be mixed with 1 oz. of cool water, infant formula or other suitable liquids • clean dropper well after each use and replace original cap on bottle Age (years) Weight (lbs) Dose infants under 2 under 24 0.3 mL children over 2 over 24 0.6 mL

Warnings Keep out of reach of children. In case of overdose get medical help or contact a Poison Control Center right away.

FDA lists 57 drug label records with SIMETHICONE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is TEENY TUMMY Gas Relief Drops used for?
Uses relieves the symptoms referred to as gas

Who makes TEENY TUMMY Gas Relief Drops?
Akron Pharma is the labeler of record for TEENY TUMMY Gas Relief Drops. 57 FDA label records share the active ingredient SIMETHICONE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does TEENY TUMMY Gas Relief 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 TEENY TUMMY Gas Relief 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.

Are there other products containing SIMETHICONE?
Yes. 57 FDA drug label records list SIMETHICONE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has TEENY TUMMY Gas Relief Drops been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

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.