Little Remedies Infant Fever/Pain Reliever

Little Remedies Infant Fever/Pain Reliever is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN. It is labelled by Medtech Products Inc. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 63029-610, application M013, label effective 20260511. It is one of 274 FDA drug label records sharing the active ingredient ACETAMINOPHEN. 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 ACETAMINOPHEN are most often described in connection with: temporarily reduces, fever relieves, minor aches, common cold, flu headache, sore throat. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses Temporarily: reduces fever relieves minor aches and pains which may be associated with the common cold, flu, headache, sore throat or toothache

Directions t his product does not contain directions or complete warnings for adult us e do not give more than directed (see overdose warning) s hake well before using find the right dose on the chart on side panel. (If possible, use weight to determine dose; otherwise, use age.) only use the enclosed AccuSafe ® syringe remove cap, insert syringe to flow restrictor and invert bottle pull back syringe until filled to prescribed level and slowly dispense the liquid into your child’s mouth (toward the inner cheek) if needed, repeat dose every 4 hours while symptoms last do not give more than 5 times in any 24-hour period (see overdose warning) do not give more than 5 days unless directed by a doctor replace cap tightly to maintain child resistance mL =milliliter Weight (lbs) Age (yrs) Dose Under 24 Under 2 Ask a doctor 24-35 2-3 5 mL

Warnings Liver warning : This product contains acetaminophen. Severe liver damage may occur if your child takes more than 5 doses in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash. If skin reaction occurs, stop use and seek medical help right away. Sore Throat Warning : If sore throat is severe, persists for more than 2 days, or is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly. Do not use: with any other products containing acetaminophen, (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. If your child is allergic to acetaminophen or any of the inactive ingredients in this product. Ask a doctor before use if the child has liver disease. Ask a doctor or pharmacist before use if the child is taking the blood thinning drug warfarin. When using this product do not exceed recommended dosage (see overdose warning) . Stop use and ask a doctor if new symptoms occur fever gets worse or lasts more than 3 days pain gets worse or lasts more than 5 days redness or swelling is present. These could be signs of a serious condition. Keep out of reach of children. Overdose Warning: Taking more than the recommended dose (overdose) can cause serious liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical even if you do not notice any signs or symptoms.

FDA lists 274 drug label records with ACETAMINOPHEN 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 Little Remedies Infant Fever/Pain Reliever used for?
Uses Temporarily: reduces fever relieves minor aches and pains which may be associated with the common cold, flu, headache, sore throat or toothache

Who makes Little Remedies Infant Fever/Pain Reliever?
Medtech Products Inc. is the labeler of record for Little Remedies Infant Fever/Pain Reliever. 274 FDA label records share the active ingredient ACETAMINOPHEN, 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 Little Remedies Infant Fever/Pain Reliever 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 Little Remedies Infant Fever/Pain Reliever 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 ACETAMINOPHEN?
Yes. 274 FDA drug label records list ACETAMINOPHEN 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 Little Remedies Infant Fever/Pain Reliever 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.