FDA.reportPublic FDA data

CVS Nighttime Children's Cold & Cough Relief

Manufacturer
CVS PHARMACY
Effective date
2026-08-19
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
daily-update
Hydrated at
2026-08-21 02:02:02

Label at a glance#

ProductCVS Nighttime Childrens Cold and Cough Multi-Symptom Relief
Active ingredientCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE
Label structure9 sections

Indications and uses

temporarily relieves cold symptoms: ▪ cough due to minor throat & bronchial irritation ▪ sneezing ▪ runny nose

Dosage and administration

▪ take only as directed ▪ do not exceed 4 doses per 24 hrs. ▪ only use the dose cup provided adults & children 12 yrs & over 30 mL every 6 hrs. children 6 to under 12 yrs 15 mL every 6 hrs. children 4 to under 6 yrs do not use unless directed by a doctor children under 4 yrs do not use

Storage and handling

▪ each 15 mL contains: potassium 5 mg, sodium 5 mg ▪ sugar free ▪ aspirin free ▪ 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 15 mL) 		Purpose

Chlorpheniramine maleate 2 mg

Antihistamine

Dextromethorphan HBr 15 mg

Cough suppressant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves cold symptoms:

  • cough due to minor throat & bronchial irritation
  • sneezing
  • runny nose

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • 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.
  • to make a child sleepy

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • glaucoma
  • 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
  • trouble urinating due to enlarged prostate gland

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, & tranquilizers may increase drowsiness

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • cough persists more than 1 week, tends to recur or is accompanied by fever, rash, or persistent headache.

These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • take only as directed
  • do not exceed 4 doses per 24 hrs.
  • only use the dose cup provided

adults & children 12 yrs & over

30 mL every 6 hrs.

children 6 to under 12 yrs

15 mL every 6 hrs.

children 4 to under 6 yrs

do not use unless directed by a doctor

children under 4 yrs

do not use

Other information

STORAGE AND HANDLING SECTION

  • each 15 mL contains: potassium 5 mg, sodium 5 mg
  • sugar free
  • aspirin free
  • store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, FD&C Red No. 40, flavor, potassium citrate, potassium sorbate, propylene glycol, purified water, sodium benzoate, sorbitol, sucrose

Questions or comments?

OTC - QUESTIONS SECTION

1-866-467-2748

PRINCIPAL DISPLAY PANEL - 236 ml Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredients in Children’s Vicks Nyquil™ Cold & Cough*

NDC 51316-752-08

Nighttime

Childrens

Cold & Cough

Chlorpheniramine maleate 2 mg,

Dextromethorphan HBr 15 mg

  • Sneezing
  • Runny Nose
  • Cough

No Added Alcohol, Acetaminophen Free

Berry Flavor

Naturally and Artificially Flavored

8 FL OZ (236 ml)

DISTRIBUTED BY:

TAMPER EVIDENT: Do not use if printed shrink band is missing or broken.

*This product is not manufactured or distributed by Procter & Gamble, the distributor of Children’s Vicks® Nyquil™ Cold & Cough.

CVS Nighttime Children's cold and cough Berry Flavor
CVS Nighttime Children's cold and cough Berry Flavor

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51316-75251316-752-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHLORPHENIRAMINE MALEATEV1Q0O9OJ9ZACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C RED NO. 40WZB9127XOAIACT
POTASSIUM CITRATEEE90ONI6FFIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52025-12-10full-release2026-06-01 01:21:42

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
CVS Nighttime Childrens Cold and Cough Multi-Symptom ReliefCHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDECVS PHARMACYd66b1a2e-49b6-473b-acec-2694c73ce8b42026-08-19WarningsExact identifier
ndc (package): 51316-752-08
ndc (product): 51316-752
ndc11 (package): 51316075208
spl id: cf993198-8b96-4dec-9658-927875ca5b43
spl set id: d66b1a2e-49b6-473b-acec-2694c73ce8b4

Reported adverse events (FAERS/openFDA)#

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