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infants pain and fever drug information

ACETAMINOPHEN
CVS Pharmacy · ORAL

Product NDC: 59779-590

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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 nameACETAMINOPHEN
Labeler / manufacturerCVS Pharmacy
RouteORAL
Drug classDrug class not supplied in source label
Product NDC59779-590
Label effective date2026-09-03

Official product label reference

infants pain and fever — CVS Pharmacy

This page contains 13 source sections for ACETAMINOPHEN, oral route. Label set 53b06c48-598e-41ad-ac7a-5508c195535c, version 7.

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

Uses temporarily: • reduces fever • relieves minor aches and pains due to: • the common cold • flu • headache • sore throat • toothache

Purpose

Purpose Pain reliever/fever reducer
Dosage and administration — label text
Directions • this product does not contain directions or complete warnings for adult use • do not give more than directed (see overdose warning) • shake well before using • mL = milliliter • find right dose on chart. If possible, use weight to dose; otherwise, use age. • push air out of syringe. Insert syringe tip into bottle opening. • flip bottle upside down. Pull yellow part of syringe to the first dose line and then push product back into bottle. • pull yellow part of syringe until it reaches and stays at the correct dose • dispense liquid slowly into child’s mouth, toward inner cheek • repeat dose every 4 hours while symptoms last • do not give more than 5 times in 24 hours • replace cap tightly to maintain child resistance Dosing Chart Weight (lb) Age (yr) Dose (mL)* under 24 under 2 years ask a doctor 24-35 2-3 years 5 mL * or as directed by a doctor Attention: use only enclosed syringe specifically designed for use with this product. Do not use any other dosing device. Table text from source: | Dosing Chart | Weight (lb) | Age (yr) | Dose (mL)* | under 24 | under 2 years | ask a doctor | 24-35 | 2-3 years | 5 mL
Warnings
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 a 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, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • if your child has ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if your child has liver disease Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin When using this product do not exceed recommended dose (see overdose warning) Stop use and ask a doctor if • new symptoms occur • pain gets worse or lasts more than 5 days • fever gets worse or lasts more than 3 days • redness or swelling is present. These could be signs of a serious condition. Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical even if you do not notice any signs or symptoms.
Active ingredient
Active ingredient (in each 5 mL) Acetaminophen 160 mg
Do not use
Do not use • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • if your child has ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use
Ask a doctor before use if your child has liver disease Stop use and ask a doctor if • new symptoms occur • pain gets worse or lasts more than 5 days • fever gets worse or lasts more than 3 days • redness or swelling is present. These could be signs of a serious condition.
Ask a doctor or pharmacist
Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin
While using this medicine
When using this product do not exceed recommended dose (see overdose warning)
Child safety
Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical even if you do not notice any signs or symptoms.
Unclassified section
Other information • store at 20-25ºC (68-77ºF) • do not use if printed neckband is broken or missing
Inactive ingredient
Inactive ingredients anhydrous citric acid, calcium sulfate, carrageenan, flavor, glycerin, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, tribasic sodium phosphate
Questions
Questions or comments ? 1-800-719-9260

Official sources and product identifiers

Substances listed: ACETAMINOPHEN

RxNorm identifiers: 307668

Package NDC codes

59779-590-16, 59779-590-10, 59779-590-26

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.