Infants Gas Relief Drops

Infants Gas Relief Drops is an FDA-registered drug product whose active ingredient is SIMETHICONE. It is labelled by DOLGENCORP INC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 55910-790, application M002, label effective 20260903. 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: discomfort infant, gas frequently, caused air, swallowing certain, formulas foods. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses relieves the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods

Directions ▪ shake well before using ▪ find right dose on chart below. if possible, use weight to dose; otherwise use age. ▪ Only use the enclosed syringe. Do not use any other syringe, dropper, spoon or dosing device when giving this medicine to your child. ▪ remove cap and insert syringe into the prescribed level. ▪ pull syringe up until filled to the prescribed level. If you pass the prescribed level, simply push syringe back until you have reached the desired level. slowly dispense the liquid into your child’s mouth (towards inner chick). ▪ 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. ▪ dosage can also be mixed with 1 oz. cool water, infant formula or other suitable liquids ▪ replace cap tightly to maintain child resistance ▪ mL= milliliter Age (yr) Weight (lb) Dose( mL) infants under 2 under 24 0.3 children over 2 over 24 0.6

Warnings Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical even if you do not notice any sign or symptoms

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.

What is Infants Gas Relief Drops used for?
Uses relieves the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods

Who makes Infants Gas Relief Drops?
DOLGENCORP INC is the labeler of record for Infants 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 Infants 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 Infants 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 Infants Gas Relief 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.