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OTC products · Product label record

Dye Free Pain and Fever Childrens drug information

ACETAMINOPHEN
Walgreens · ORAL

Product NDC: 0363-0283

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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 / manufacturerWalgreens
RouteORAL
Drug classDrug class not supplied in source label
Product NDC0363-0283
Label effective date2026-08-26

Official product label reference

Dye Free Pain and Fever Childrens — Walgreens

This page contains 14 source sections for ACETAMINOPHEN, oral route. Label set 3ea217dd-e5b9-4d4b-861a-76ce61ba3a1d, version 9.

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 temporarily 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 take more than directed (see overdose warning) shake well before using mL = milliliter use only the enclosed dosing cup designed for with this product. Do not use any other dosing device. if needed, repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours do not give more than 5 days unless directed by a doctor find the right dose on chart below. If possible, use weight to dose: otherwise, use age. *or as directed by a doctor Weight (lb) Age (year) Dose (mL)* under 24 under 2 ask a doctor 24-35 2-3 5 mL 36-47 4-5 7.5 ml 48-59 6-8 10 mL 60-71 9-10 12.5 mL 72-95 11 15 mL Table text from source: | Weight (lb) | Age (year) | Dose (mL)* | under 24 | under 2 | ask a doctor | 24-35 | 2-3 | 5 mL | 36-47 | 4-5 | 7.5 ml | 48-59 | 6-8 | 10 mL | 60-71 | 9-10 | 12.5 mL | 72-95 | 11 | 15 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 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 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 redness or swelling is present pain gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days These could be signs of a serious condition. Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 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 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
Ask a doctor before use if your child has liver disease.
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)
When to stop use and seek help
Stop use and ask a doctor if new symptoms occur redness or swelling is present pain gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days These could be signs of a serious condition.
Child safety
Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.
Storage and handling
Other information each 5 mL contains :sodium 2 mg store between 20-25ºC (68-77ºF) do not refrigerate see bottom panel for lot number and expiration date
Inactive ingredient
Inactive ingredients butylparaben, carboxymethylcellulose sodium, citric acid, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum
Questions
Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Official sources and product identifiers

Substances listed: ACETAMINOPHEN

RxNorm identifiers: 307668

Package NDC codes

0363-0283-04

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.