Childrens Pain Plus Fever Relief Suspension
FDA Label NDC 51316-569

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Childrens Pain Plus Fever Relief (NDC 51316-569). 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 5 ml), 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 5 Ml)

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)
  • ▪shake well before using
  • ▪mL = milliliter
  • ▪find right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • ▪remove the child protective cap and squeeze your child's dose into the dosing cup
  • ▪repeat dose every 4 hours while symptoms last
  • ▪do not give more than 5 times in 24 hours
    • Weight (lb)Age (yr)Dose (mL) **

    under 24

    under 2 years

    ask a doctor

    24-35

    2-3 years

    5 mL

    36-47

    4-5 years

    7.5 mL

    48-59

    6-8 years

    10 mL

    60-71

    9-10 years

    12.5 mL

    72-95

    11 years

    15 mL

    Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other Information

  • ▪each 5 mL contains: sodium 2 mg
  • ▪store at room temperature

Inactive Ingredients

carboxymethylcellulose sodium, anhydrous citric acid, flavors, glycerin, microcrystalline cellulose, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol solution, sucralose, xanthan gum

Questions Or Comments?

1-866-467-2748

Principal Display Panel

Compare to the active ingredient in Children’s Tylenol® Dye-Free Oral Suspension*

NDC 51316-569-04

Children’s

Pain+Fever Relief

Acetaminophen
Oral Suspension

Pain Reliever-Fever Reducer

  •  No Added Alcohol
  •  Sugar Free
  •  Dye Free
  •  Aspirin Free
  •  Ibuprofen Free
  •  No Parabens

    • Ages 2-11 Years
    Natural Strawberry Flavor

    4 FL. OZ. (120 mL)
    160 mg per 5 mL

    *This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., the distributor of Children’s Tylenol® Dye-Free Oral Suspension.

    Distributed by:

    Children's Pain+ Fever Relief Oral Suspension Strawberry Flavor (Childrens Tylenol 01)

    Children's Pain+ Fever Relief Oral Suspension Strawberry Flavor (Childrens Tylenol 01)

* Please review the disclaimer below.