FDA.reportPublic FDA data

Cold and Congestion

Manufacturer
Walgreens
Effective date
2023-10-09
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:56:33

Label at a glance#

ProductCold and Congestion Childrens Nighttime
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

temporarily relieves these symptoms occuring with a cold, hay fever, or other upper respiratory allergies nasal congestion cough runny nose sneezing itchy, watery eyes itching of the nose or throat

Dosage and administration

do not take more than 6 doses in any 24-hour period do not exceed recommended dosage measure only with dosing cup provided. Do not use any other dosing device. keep dosing cup with product mL = milliliter  age  dose adults and children 12 years and over 20 mL every 4 hours  children 6 to 11 years  10 mL every 4 hours  children under 6 years do not use

Storage and handling

each 10 mL contains: sodium 6mg store at 20-25°C (68-77°F) Do not refrigerate protect from light

Label contents#

Full prescribing information#

Active ingredients (in each 10 mL)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCI 12.5 mg

Phenylephrine HCI 5 mg

Purposes

OTC - PURPOSE SECTION

Antihistamine/Cough suppressant

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these symptoms occuring with a cold, hay fever, or other upper respiratory allergies
    • nasal congestion
    • cough
    • 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.
  • with any other product containing diphenhydramine, even one used on skin.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlem (mucus)
  • a breathing problem or chronic cough that last or as occurs with smoking, asthma, chronic bronchitis, or emphysena. 

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking any other oral nasal decongestant or stimulant
  • 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

SPL UNCLASSIFIED SECTION

  • you get nervous, dizzy or sleepless
  • symptoms do not get better within 7 days or occur with a fever
  • cough lasts more than 7 days, comes back, or is accompanied by a 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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than 6 doses in any 24-hour period
  • do not exceed recommended dosage
  • measure only with dosing cup provided. Do not use any other dosing device.
  • keep dosing cup with product
  • mL = milliliter
 age dose
adults and children 12 years and over20 mL every 4 hours
 children 6 to 11 years 10 mL every 4 hours
 children under 6 yearsdo not use

Other information

STORAGE AND HANDLING SECTION

  • each 10 mL contains: sodium 6mg
  • store at 20-25°C (68-77°F)
  • Do not refrigerate
  • protect from light

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium anhydrous citric acid, EDTA disodium, FD&C blue #1, FD&C red # 40, flavor, maltitol, propylene glycol, purified water, sodium benzoate, trisodium citrate dihydrate

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST 

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

children's

COLD & CONGESTION

DIPHENHYDRAMINE HCI 12.5 mg / ANTIHISTAMINE / COUGH SUPPRESSANT

PHENYLEPHRINE HCI 5 mg / NASAL DECONGESTANT

Compare-to Children's Dimetapp® Nighttime Cold & Congestion active ingredients††

  • Nighttime
  • Alcohol Free
  • 6 years & older

FL OZ (mL)

GRAPE FLAVOR

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY : WALGREEN CO

200 WILMOT RD., DEERFIELD, IL 60015

walgreens.com

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

WALGREENS Children's Cold & Congestion Grape Flavor
WALGREENS Children's Cold & Congestion Grape Flavor

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1236048diphenhydrAMINE HCl 6.25 MG / phenylephrine HCl 2.5 MG in 5 mL Oral SolutionPSN6
1236048diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD6
1236048diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral SolutionSY6
1236048diphenhydramine HCl 6.25 MG / phenylephrine HCl 2.5 MG per 5 ML Oral SolutionSY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-0058-042023-10-09C16284748780-1f386c649-a3b1-0266-e053-dadaa90a7c1aDrug Facts
0363-0058-042023-01-30C16284748780-1f386c649-a3b1-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0058-04Cold and CongestionChildrens Nighttime118 mL in 1 BOTTLE, PLASTICLIQUID1186

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0058COLD AND CONGESTION CHILDRENS NIGHTTIME (DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCL) LIQUID [WALGREENS]6Current NDC, Legacy NDC, 1 package rows20231010_a7847413-e556-4f88-8a7f-a8528afbe927.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
0363-00580363-0058-04

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
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
ACESULFAME POTASSIUM23OV73Q5G9IACT
MALTITOLD65DG142WKIACT
EDETATE DISODIUM7FLD91C86KIACT

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
Cold and Congestion Childrens NighttimeDIPHENHYDRAMINE HCI, PHENYLEPHRINE HCLWalgreensa7847413-e556-4f88-8a7f-a8528afbe9272023-10-09WarningsExact identifier
ndc (package): 0363-0058-04
ndc (product): 0363-0058
ndc11 (package): 00363005804
spl id: 7febd3a1-07d3-4499-bd13-0b876e1c20f8
spl set id: a7847413-e556-4f88-8a7f-a8528afbe927

Reported adverse events (FAERS/openFDA)#

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