Vicks childrens

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2022-10-31
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:50:02

Label at a glance#

ProductVicks childrens Cough Congestion
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, GUAIFENESIN
Label structure10 sections

Indications and uses

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.

Dosage and administration

take only as directed use 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 7.5 mL every 4 hrs 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

Drug Facts

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.

Overdose warning

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
  • use 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 7.5 mL every 4 hrs
children under 4 yrs do 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

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

Made in Canada

PRINCIPAL DISPLAY PANEL - 177 ml Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VICKS®

children's

Cough

Congestion

Non-Drowsy

Phenylephrine HCI - nasal decongestant
Dextromethorphan HBr - cough suppressant
Guaifenesin - expectorant

FREE of:

Artificial Dyes & Flavors,

High Fructose Corn Syrup & Alcohol

  • Cough
  • Chest congestion
  • Stuffy nose

Ages 4+

6 FL OZ (177 ml)

895895

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37000-895-062021-02-12C16284748780-1ba0f9c33-3b01-a910-e053-dadaa90a0b85VICKS ® children's Cough Congestion
37000-895-062021-01-29C16284748780-1ba0f9c33-3b01-a910-e053-dadaa90a0b85VICKS ® children's Cough Congestion

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37000-89537000-895-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

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
f19c4f9b-5d85-695e-e053-2a95a90a5b79873699e2-5693-8d9f-e053-2991aa0acc112023-01-06WarningsExact identifier
spl set id: 873699e2-5693-8d9f-e053-2991aa0acc11

Reported adverse events (FAERS/openFDA)#

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