Vicks ®

Vicks ®
SPL v10
SPL
SPL Set ID 87231460-8b45-b995-e053-2a91aa0a6c43
Route
ORAL
Published
Effective Date 2023-09-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (12.5 mg) Phenylephrine (5 mg)
Inactive Ingredients
Glycerin Sodium Benzoate Polysorbate 20 Sucralose Sodium Citrate Sodium Chloride Anhydrous Citric Acid Propylene Glycol Water Saccharin Sodium Sorbitol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-04-22
Description

Drug Facts

Purpose

Antihistamine/Cough suppressant Nasal decongestant

Medication Information

Purpose

Antihistamine/Cough suppressant

Nasal decongestant

Description

Drug Facts

Uses

temporarily relieves common cold symptoms:

  • nasal congestion
  • runny nose & sneezing
  • cough due to minor throat and bronchial irritation
Section 34088-5

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

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Directions
  • 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

Do Not Use
  • 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.
Questions?

1-800-362-1683

Other Information
  • each 15 mL contains:sodium 44 mg
  • store at no greater than 25ºC.
Inactive Ingredients

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

When Using This Product
  • 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
  • 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.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Active Ingredients (in Each 15 Ml)

Diphenhydramine HCl 12.5 mg

Phenylephrine HCl 5 mg

Ask A Doctor Before Use If You Have
  • 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
Principal Display Panel 177 Ml Bottle Label

VICKS ®

children's

Cough

Congestion Night

Phenylephrine HCI - nasal decongestant

Diphenhydramine HCI - antihistamine/cough suppressant

FREEof:

Artificial Dyes & Flavors,

High Fructose Corn Syrup & Alcohol

  • Cough
  • Runny nose
  • Stuffy nose
  • Sneezing

Ages 6+

6 FL OZ (177 ml)

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers

Structured Label Content

Uses

temporarily relieves common cold symptoms:

  • nasal congestion
  • runny nose & sneezing
  • cough due to minor throat and bronchial irritation
Section 34088-5 (34088-5)

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Purpose

Antihistamine/Cough suppressant

Nasal decongestant

Directions
  • 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

Do Not Use (Do not use)
  • 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.
Questions?

1-800-362-1683

Other Information (Other information)
  • each 15 mL contains:sodium 44 mg
  • store at no greater than 25ºC.
Inactive Ingredients (Inactive ingredients)

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

When Using This Product (When using this product)
  • 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 (Stop use and ask a doctor if)
  • 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.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Active Ingredients (in Each 15 Ml) (Active ingredients (in each 15 mL))

Diphenhydramine HCl 12.5 mg

Phenylephrine HCl 5 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • 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
Principal Display Panel 177 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 177 ml Bottle Label)

VICKS ®

children's

Cough

Congestion Night

Phenylephrine HCI - nasal decongestant

Diphenhydramine HCI - antihistamine/cough suppressant

FREEof:

Artificial Dyes & Flavors,

High Fructose Corn Syrup & Alcohol

  • Cough
  • Runny nose
  • Stuffy nose
  • Sneezing

Ages 6+

6 FL OZ (177 ml)

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:08.608819 · Updated: 2026-03-14T23:10:23.192014