FDA.reportPublic FDA data

Vicks Childrens

Manufacturer
Procter & Gamble Manufacturing Company
Effective date
2023-10-13
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
legacy-cache
Hydrated at
2026-08-01 21:24:15

Label at a glance#

ProductVicks Childrens Cold Multi Symptom
Active ingredientACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE
Label structure12 sections

Indications and uses

temporarily relieves common cold/flu symptoms: nasal congestion cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever

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 ask 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. Do not refrigerate.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (in each 15 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/Fever reducer

Cough suppressant

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • cough due to minor throat & bronchial irritation
  • sore throat
  • headache
  • minor aches & pains
  • fever

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

This product contains acetaminophen. Severe liver damage may occur if

  • adult takes more than 4 doses (30 mL each) in 24 hours, which is the maximum daily amount for this product
  • child takes more than 4 doses (15 mL each) in 24 hours, which is the maximum daily amount for this product
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks daily while using this product

Allergy Alert:

SPL UNCLASSIFIED SECTION

Acetaminophen may cause severe skin reactions. Symptoms may include:

  • Skin reddening
  • Blisters
  • Rash

If a skin reaction occurs, stop use and seek medical help right away

Sore throat warning

SPL UNCLASSIFIED SECTION

If sore throat is severe, persists for more than 2 days, is accompanied or is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

OTC - DO NOT USE SECTION

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • 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

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • peristent or chronic cough such 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 the blood thinning drug warfarin

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
  • pain, nasal congestion or cough gets worse or lasts more than 5 days (children) 7 days (adults)
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back, or occurs with rash or headache that lasts.
    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. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

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. Do not refrigerate.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

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 - 177 ml Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VICKS ®

children's

Cold

MULTI-SYMPTOM

Acetaminophen - pain reliever/fever reducer
Dextromethorphan HBr - cough suppressant

Phenylephrine HCl - nasal decongestant

FREE of:

Artificial Dyes & Flavors,
High Fructose Corn Syrup & Alcohol

  • Aches, Fever
  • Sore Throat
  • Cough
  • Stuffy nose

Ages 6+

6 FL OZ (177 ml)

759759

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37000-759-062021-02-12C16284748780-1ba0f9c33-5907-a910-e053-dadaa90a0b85VICKS ® children's Cold MULTI-SYMPTOM
37000-759-062021-01-29C16284748780-1ba0f9c33-5907-a910-e053-dadaa90a0b85VICKS ® children's Cold MULTI-SYMPTOM

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37000-75937000-759-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUCRALOSE96K6UQ3ZD4IACT
SORBITOL506T60A25RIACT
SODIUM CHLORIDE451W47IQ8XIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
XANTHAN GUMTTV12P4NEEIACT
BETA CAROTENE01YAE03M7JIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE1Q73Q2JULRIACT
ACETAMINOPHEN362O9ITL9DACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB

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
079b569d-fc3e-e36b-e063-6294a90a637887346412-e8d4-6502-e053-2a91aa0a83312023-10-13WarningsExact identifier
spl id: 079b569d-fc3e-e36b-e063-6294a90a6378
spl set id: 87346412-e8d4-6502-e053-2a91aa0a8331

Reported adverse events (FAERS/openFDA)#

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