Vicks ®

Vicks ®
SPL v5
SPL
SPL Set ID f1d67797-c806-261d-e053-2a95a90a3c15
Route
ORAL
Published
Effective Date 2023-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg) Guaifenesin (200 mg) Phenylephrine (5 mg) Diphenhydramine (12.5 mg)
Inactive Ingredients
Glycerin Propylene Glycol Water Saccharin Sodium Sodium Benzoate Sodium Chloride Sodium Citrate Sorbitol Sucralose Anhydrous Citric Acid Polysorbate 20

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-07-09

Description

Vicks children's Cough Congestion (Night)

Purpose

Antihistamine/Cough suppressant Nasal decongestant


Medication Information

Purpose

Antihistamine/Cough suppressant

Nasal decongestant

Description

Vicks children's Cough Congestion (Night)

Uses

temporarily relieves common cold symptoms:

  • nasal congestion
  • runny nose & sneezing
  • cough due to minor throat and bronchial irritation
Section 42229-5

Vicks children's Cough Congestion (Night)

Section 50565-1

Keep out of reach of children.

Section 50567-7

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

Section 53414-9

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

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.

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 Kit Carton

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)

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers

In Case of Overdose, Get Medical Help Or Contact A Poison Control Center Right Away.


Structured Label Content

Uses

temporarily relieves common cold symptoms:

  • nasal congestion
  • runny nose & sneezing
  • cough due to minor throat and bronchial irritation
Section 42229-5 (42229-5)

Vicks children's Cough Congestion (Night)

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50567-7 (50567-7)

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

Section 53414-9 (53414-9)

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

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.

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 Kit Carton (PRINCIPAL DISPLAY PANEL - Kit Carton)

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)

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

taking sedatives or tranquilizers

In Case of Overdose, Get Medical Help Or Contact A Poison Control Center Right Away. (In case of overdose, get medical help or contact a Poison Control Center right away.)


Advanced Ingredient Data


Raw Label Data

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