Childrens Pain And Fever Powder
FDA Label NDC 0363-5101

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreens Co. for the product Childrens Pain And Fever (NDC 0363-5101). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient (in each packet), purpose, uses, liver warning, do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

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.

Active Ingredient (In Each Packet)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

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

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

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 is allergic to acetaminophen or any of the inactive ingredients in this product

Otc - Ask Doctor

Ask a doctor before use if your child has liver disease

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin

Otc - When Using

When using this product do not exceed recommended dose (see overdose warning)

Stop Use And Ask A Doctor If

  • ▪pain gets worse or lasts more than 5 days
  • ▪fever gets worse or lasts more than 3 days
  • ▪new symptoms occur
  • ▪redness or swelling is present

    • These could be signs of a serious condition.

Otc - Keep Out Of Reach Of Children

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 for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • ▪this product does not contain directions or complete warnings for adult use.
  • ▪do not give more than directed (see overdose warning)
  • ▪find right dose on chart. If possible, use weight to dose; otherwise, use age.
  • ▪tear packet and pour powder on your child's tongue
  • ▪repeat dose every 4 hours while symptoms last
  • ▪do not give more than 5 times in 24 hours
    • packets
    Weight (lb)Age (yr)Dose (powder)

    under 48

    under 6 years

    do not use

    48-59

    6-8 years

    2 packets

    60-71

    9-10 years

    2 packets

    72-95

    11 years

    3

Other Information

  • store at room temperature

    • TAMPER EVIDENT: DO NOT USE IF PACKET IS TORN OR DAMAGED

Inactive Ingredients

citric acid, flavor, gelatin, isomalt, silica, sucralose

Questions Or Comments?

call 1-866-467-2748

Principal Display Panel

NDC 0363-5101-18

Children's Pain + Fever Dissolve Packs

ACETAMINOPHEN
Pain Reliever/Fever Reducer

  • Aspirin Free
  • Ibuprofen Free
  • No water needed
  • Dissolves in seconds

    • Ages 6-11

    18 Packets*
    160 mg
    each packet

    Wild Berry Flavor

    Naturally and Artificially Flavored

    *Packets of Powder

    Pour powder on your child’s tongue

    IMPORTANT: Keep this carton for future reference on full labeling.

    *This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of the registered trademark Children’s Tylenol® Dissolve Packs.

    Distributed by:

    WALGREEN CO.

    200 WILMOT RD., CEERFIELD, IL 60015

    Children's Pain And Fever Dissolve Packs Acetaminophen (Tylenol 01)

    Children's Pain And Fever Dissolve Packs Acetaminophen (Tylenol 01)

* Please review the disclaimer below.