FDA.reportPublic FDA data

Walgreen Childrens

Manufacturer
WALGREENS CO.
Effective date
2025-11-26
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:18:16

Label at a glance#

ProductWalgreen Childrens COLD PLUS COUGH PLUS SORE THROAT
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure9 sections

Indications and uses

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

Dosage and administration

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...

Storage and handling

each 5 mL contains: sodium 3 mg store at room temperature

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each 5 mL)Purposes

Acetaminophen 160 mg

Pain reliever/fever reducer

Dextromethorphan HBr 5 mg

Cough suppressant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • liver disease
  • persistent or chronic cough such as occurs with asthma
  • cough that occurs with too much phlegm (mucus)

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

When using this product

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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 SECTION

Keep out of reach of children.

Overdose warning

SPL UNCLASSIFIED SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed (seeoverdose 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

STORAGE AND HANDLING SECTION

  • each 5 mL contains:sodium 3 mg
  • store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

1-866-467-2748

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.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
Walgreens Children's Cold + Cough + Sore Throat Relief 4 FL OZ 120 mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1370113acetaminophen 160 MG / dextromethorphan HBr 5 MG in 5 mL Oral SuspensionPSN4
1370113acetaminophen 32 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral SuspensionSCD4
1370113acetaminophen 160 MG / dextromethorphan HBr 5 MG per 5 ML Oral SuspensionSY4
1370113APAP 160 MG / dextromethorphan hydrobromide 5 MG per 5 ML Oral SuspensionSY4
1370113APAP 32 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML Oral SuspensionSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-6504-04Walgreen ChildrensCOLD PLUS COUGH PLUS SORE THROAT120 mL in 1 BOTTLESUSPENSION1204
0363-6504-04Walgreen ChildrensCOLD PLUS COUGH PLUS SORE THROAT1 in 1 CARTONSUSPENSION14

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-65040363-6504-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
D&C RED NO. 339DBA0SBB0LIACT
EDETATE DISODIUM7FLD91C86KIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
SORBITOL SOLUTION8KW3E207O2IACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreen Childrens COLD PLUS COUGH PLUS SORE THROATACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDEWALGREENS CO.801880b2-6116-4d26-a7bf-a669eef6ad8b2025-11-26WarningsExact identifier
ndc (package): 0363-6504-04
ndc (product): 0363-6504
ndc11 (package): 00363650404
spl id: 447fe94d-279e-8f04-e063-6294a90a26ce
spl set id: 801880b2-6116-4d26-a7bf-a669eef6ad8b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.