FDA.reportPublic FDA data

childrens Wal Tussin Cough and Cold

Manufacturer
WALGREEN CO.
Effective date
2021-01-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:37:33

Label at a glance#

Productchildrens Wal Tussin Cough and Cold
Active ingredientchlorpheniramine maleate, dextromethorphan hydrobromide
Label structure6 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS (in each 10 mL)

OTC - ACTIVE INGREDIENT SECTION

Chlorpheniramine maleate, USP 2 mg

Dextromethorphan HBr, USP 15 mg

PURPOSES

OTC - PURPOSE SECTION

Antihistamine

Cough suppressant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat

WARNINGS

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • to sedate a child or to make a child sleepy
  • if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • a cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • do not use more than directed
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Stop use and ask a doctor if

OTC - STOP USE SECTION

cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • measure only with dosing cup provided
  • keep dosing cup with product
  • mL = milliliter
  • do not take more than 4 doses in any 24-hour period
agedose

Children under 6 years

do not use

children 6 to under 12 years

10 mL every 6 hours

adults and children 12 years and older

20 mL every 6 hours

Other information

OTHER SAFETY INFORMATION

  • each 10 mL contains: sodium 7 mg
  • store at room temperature, Do not refrigerate.
  • Do not use if printed seal under cap is torn or missing

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

citric acid, FD&C red no. 40,glycerin, lactic acid, natural and artificial flavors,

propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

1-866-467-2748

PRODUCT PACKAGING

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Walgreens

Compare to Children’s Robitussin® Cough & Cold Long–Acting active ingredients ††

New

children’s Wal-Tussin® Cough & Cold

CHLORPHENIRAMINE MALEATE USP 2 mg / Antihistamine

DEXTROMETHORPHAN HBr, USP 15 mg/ Cough Suppressant

  • Relief of cough & runny nose
  • 6 YEARS & OLDER

FRUIT PUNCH FLAVOR

NATURALLY AND ARTIFICIALLY FLAVORED

6 YEARS & OLDER

4 FL OZ (118 mL)

WALGREENS PHARMACIST RECOMMENDED

Walgreens Pharmacist Survey

IMPORTANT: KEEP THIS CARTON FOR FUTURE REFERENCE ON FULL LABELING

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

Walgreens 100% SATISFACTION GUARANTEED

walgreens.com ©2017 Walgreen Co.

childrens Wal- Tussin Cough & Cold 4 FL OZ Fruit Punch Flavor
childrens Wal- Tussin Cough & Cold 4 FL OZ Fruit Punch Flavor

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1111440chlorpheniramine maleate 1 MG / dextromethorphan HBr 7.5 MG in 5 mL Oral SolutionPSN3
1111440chlorpheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1.5 MG/ML Oral SolutionSCD3
1111440chlorpheniramine maleate 1 MG / dextromethorphan hydrobromide 7.5 MG per 5 ML Oral SolutionSY3
1111440chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG per 10 ML Oral SolutionSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORPHENIRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-0745-042023-01-30C16284748780-1f386c64a-0ff5-0266-e053-dadaa90a7c1aChildren’s Wal-Tussin ® Cough & Cold Fruit Punch Flavor 4 FL OZ

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0745-04childrens Wal Tussin Cough and Cold1 in 1 CARTONLIQUID13
0363-0745-04childrens Wal Tussin Cough and Cold118 mL in 1 BOTTLELIQUID1183

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0745CHILDRENS WAL TUSSIN COUGH AND COLD (CHLORPHENIRAMINE MALEATE, DEXTROMETRORPHAN HBR) LIQUID [WALGREEN CO.]3Legacy NDC, 2 package rows20210130_35f6edb5-923c-4bf7-ab23-31bad90448ac.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-07450363-0745-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
chlorpheniramine maleateV1Q0O9OJ9ZACTIB
dextromethorphan hydrobromide9D2RTI9KYHACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
LACTIC ACID, UNSPECIFIED FORM33X04XA5ATIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT

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
3f0f622a-4390-4e0a-892b-08c572be59f535f6edb5-923c-4bf7-ab23-31bad90448ac2021-01-29WarningsExact identifier
spl id: 3f0f622a-4390-4e0a-892b-08c572be59f5
spl set id: 35f6edb5-923c-4bf7-ab23-31bad90448ac

Reported adverse events (FAERS/openFDA)#

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