Walgreen Childrens Suspension
FDA Label NDC 0363-6504

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 Walgreen Childrens (NDC 0363-6504). 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, otc - purpose, uses, liver warning, do not use, ask a doctor before use if your child has, otc - ask doctor/pharmacist, otc - when using, 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.

Otc - Purpose

Active ingredients (in each 5 mL)Purposes

Acetaminophen 160 mg

Pain reliever/fever reducer

Dextromethorphan HBr 5 mg

Cough suppressant

Uses

  • ▪temporarily relieves the following cold/flu symptoms:
    • ▪minor aches and pains
    • ▪headache
    • ▪sore throat
    • ▪cough
    • ▪temporarily reduces fever

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.
  • ▪in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
  • ▪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
  • ▪persistent or chronic cough such as occurs with asthma
  • ▪cough that occurs with too much phlegm (mucus)

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

Stop Use And Ask A Doctor If

  • ▪pain or cough 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
  • ▪cough comes back or occurs with rash or headache that lasts

    • 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 at 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 36

    under 4 years

    do not use

    36-47

    4 to 5 years

    5 mL

    48-95

    6 to 11 years

    10 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 3 mg
  • store at room temperature

Inactive Ingredients

carboxymethylcellulose sodium, anhydrous citric acid, D&C red no. 33, disodium edetate, FD&C red no. 40, 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 ingredients in Children’s Tylenol® Cold + Cough + Sore Throat*

NDC 0363-6504-04

Children's

Cold + Cough

+ Sore Throat Relief

Acetaminophen, Pain Reliever-Fever Reducer
Dextromethorphan HBr, Cough Suppressant

Oral Suspension

Ages 4-11 Years

  • Fever
  • Sore Throat
  • Cough

    • Ibuprofen free, aspirin free,

    No added alcohol

    BubblegumFlavor

    Naturally and Artificially Flavored

    4 FL OZ (120 mL)

    *This product is not manufactured or distributed by Johnson & Johnson Consumer Inc, distributor of Children’s Tylenol® Cold + Cough + Sore Throat.

    TAMPER-EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAPS IS TORN OR MISSING.

    Walgreens Children's Cold + Cough + Sore Throat Relief 4 Fl Oz 120 mL (Childrens 01)

    Walgreens Children's Cold + Cough + Sore Throat Relief 4 Fl Oz 120 mL (Childrens 01)

* Please review the disclaimer below.