FDA.reportPublic FDA data

VICKS CHILDRENS COUGH CONGESTION - The Procter & Gamble Manufacturing Company

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2026-03-26
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:51:47

Label at a glance#

ProductVICKS CHILDRENS COUGH CONGESTION
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure20 sections

Indications and uses

temporarily relieves common cold symptoms: nasal congestion runny nose & sneezing cough due to minor throat and bronchial irritation

Dosage and administration

take only as directed only use the dose cup provided do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL every 4 hrs  children 6 to under 12 yrs 15 mL every 4 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: sodium 44 mg Store at no greater than 25ºC.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Vicks children's Cough Congestion (Night)

Active ingredients (in each 15 mL)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 12.5 mg

Phenylephrine HCl 5 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine/Cough suppressant
Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves common cold symptoms:

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

Warnings

WARNINGS SECTION

Do not use

SPL UNCLASSIFIED SECTION

  • with any other product containing diphenhydramine, even one used on skin
  • 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

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • trouble urinating due to enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, or emphysema
  • a sodium-restricted diet

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you get nervous, dizzy or sleepless
  • symptoms do not improve within 7 days or occur with a fever
  • cough persists for more than 7 days, comes back or occurs with a 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.

SPL UNCLASSIFIED SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take only as directed
  • only use the dose cup provided
  • do not exceed 4 doses per 24 hrs
adults & children 12 yrs & over30 mL every 4 hrs 
children 6 to under 12 yrs15 mL every 4 hrs
children 4 to under 6 yrsdo not use unless directed by a doctor
children under 4 yrsdo not use

Other information

STORAGE AND HANDLING SECTION

  • each 15 mL contains:sodium 44 mg
  • Store at no greater than 25ºC.

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, flavor, glycerin, polysorbate 20, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose

Questions?

OTC - QUESTIONS SECTION

1-800-362-1683

SPL UNCLASSIFIED SECTION

DIST. BY: PROCTER & GAMBLE, CINCINNATI, OH 45202

Made in Canada

SPL UNCLASSIFIED SECTION

VICKS® childrens Cough Congestion(Day)

Active ingredients (in each 15 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purpose

OTC - PURPOSE SECTION

Cough suppressant
Expectorant

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves common cold symptoms:

  • nasal congestion
  • cough due to minor throat and bronchial irritation
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

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.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • a sodium-restricted diet

OTC - WHEN USING SECTION

When using this product, do not use more than directed.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you get nervous, dizzy or sleepless
  • symptoms do not improve within 7 days or occur with a fever
  • cough persists for more than 7 days, comes back or occurs with a 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.

OVERDOSAGE SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

SPL UNCLASSIFIED SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • take only as directed
  • only use the dose cup provided
  • do not exceed 4 doses per 24 hrs
adults & children 12 yrs & over30 mL every 4 hrs 
children 6 to under 12 yrs15 mL every 4 hrs
children 4 to under 6 yrsask a doctor
children under 4 yrsdo not use

Other information

STORAGE AND HANDLING SECTION

  • each 15 mL contains: sodium 44 mg
  • store at no greater than 25ºC

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose

Questions?

OTC - QUESTIONS SECTION

1-800-362-1683

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: Do not use if printed safety seal under cap is missing or damaged

SPL UNCLASSIFIED SECTION

DIST. BY: PROCTER & GAMBLE, CINCINNATI, OH 45202

Made in Canada

PRINCIPAL DISPLAY PANEL - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DAY & NIGHT PACK

children's Cough Congestion

Phenylephrine HCl - nasal decongestant

Dextromethorphan HBr - cough suppressant

Guaifenesin - expectorant

Non-Drowsy

FREE of:

Artificial Dyes & Flavors,

High Fructose Corn Syrup & Alcohol

  • Cough
  • Chest congestion
  • Stuffy nose

Ages 4+

children's Cough Congestion Night

Phenylephrine HCl - nasal decongestant

Diphenhydramine HCl - antihistamine/cough suppressant

Nighttime

FREE of:

Artificial Dyes & Flavors,

High Fructose Corn Syrup & Alcohol

  • Cough
  • Runny nose
  • Stuffy nose
  • Sneezing

Ages 6+

2 BOTTLES - 6 FL OZ (177 mL) EACH; TOTAL 12 FL OZ (354 mL)

997.jpg997.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2626497{1 (dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.33 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) / 1 (diphenhydramine hydrochloride 0.833 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) } PackGPCK6
26264971 daytime (dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL) / 1 nighttime (diphenhydrAMINE HCl 12.5 MG / phenylephrine HCl 5 MG in 15 mL) PackPSN6
2626496dextromethorphan HBr 0.667 MG/mL / guaiFENesin 13.33 MG/mL / phenylephrine HCl 0.333 MG/mL Oral SolutionPSN6
2166123dextromethorphan Hbr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral SolutionPSN6
2166129diphenhydrAMINE HCl 12.5 MG / phenylephrine HCl 5 MG in 15 mL Oral SolutionPSN6
2166123dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCD6
2626496dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.33 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCD6
2166129diphenhydramine hydrochloride 0.833 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCD6
26264971 daytime (dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG per 15 mL) / 1 nighttime (diphenhydramine hydrochloride 12.5 MG / phenylephrine hydrochloride 5 MG per 15 mL) PackSY6
2166123dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG per 15 ML Oral SolutionSY6
2166129diphenhydramine hydrochloride 12.5 MG / phenylephrine hydrochloride 5 MG per 15 ML Oral SolutionSY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130323900027312GTIN-13: 0323900027312
EAN-13: 0323900027312
GTIN-12: 323900027312
UPC-A: 323900027312
GTIN storage (14 digits): 00323900027312		997.jpg.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-712-06VICKS CHILDRENSCOUGH CONGESTION177 mL in 1 BOTTLE, PLASTICLIQUID177 mL5 mg in 15mL6
69423-982-06VICKS CHILDRENSCOUGH CONGESTION177 mL in 1 BOTTLE, PLASTICLIQUID177 mL5 mg in 15mL6
69423-997-12VICKS CHILDRENSCOUGH CONGESTION1 in 1 PACKAGEKIT16

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69423-99769423-997-12
69423-98269423-982-06
37000-71237000-712-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM CITRATE1Q73Q2JULRIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
SORBITOL506T60A25RIACT
POLYSORBATE 207T1F30V5YHIACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE1Q73Q2JULRIACT
GLYCERINPDC6A3C0OXIACT
SUCRALOSE96K6UQ3ZD4IACT
SODIUM CHLORIDE451W47IQ8XIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52025-10-02legacy-cache2026-10-21 23:52:51

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vicks childrens Cough CongestionPHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESINThe Procter & Gamble Manufacturing Companye2356457-9791-3710-e053-2995a90ad1402026-09-08WarningsExact identifier
ndc (package): 69423-982-06
ndc (product): 69423-982
ndc11 (package): 69423098206
Vicks childrens Cough Congestion NightPHENYLEPHRINE HYDROCHLORIDE AND DIPHENHYDRAMINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Company87231460-8b45-b995-e053-2a91aa0a6c432026-03-26WarningsExact identifier
ndc (package): 37000-712-06
ndc (product): 37000-712
ndc11 (package): 37000071206
VICKS CHILDRENS COUGH CONGESTIONDEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Companyf1d67797-c806-261d-e053-2a95a90a3c152026-03-26WarningsExact identifier
ndc (package): 69423-997-12
ndc (package): 37000-712-06
ndc (package): 69423-982-06
ndc (product): 69423-997
ndc11 (package): 69423099712
ndc11 (package): 37000071206
ndc11 (package): 69423098206
spl id: 4df61d65-70d2-069b-e063-6294a90a5073
spl set id: f1d67797-c806-261d-e053-2a95a90a3c15

Reported adverse events (FAERS/openFDA)#

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