Vicks ®

Vicks ®
SPL v7
SPL
SPL Set ID e2356457-9791-3710-e053-2995a90ad140
Route
ORAL
Published
Effective Date 2023-09-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

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

Description

Drug Facts

Purpose

Cough suppressant Expectorant Nasal decongestant


Medication Information

Purpose

Cough suppressant

Expectorant

Nasal decongestant

Description

Drug Facts

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.
Section 42229-5

Drug Facts

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 7.5 mL every 4 hrs
children under 4 yrs do not use

Do Not Use

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, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose

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)

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

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

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)


Structured Label Content

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.
Section 42229-5 (42229-5)

Drug Facts

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

Cough suppressant

Expectorant

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 7.5 mL every 4 hrs
children under 4 yrs do not use

Do Not Use (Do not use)

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, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose

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))

Dextromethorphan HBr 10 mg

Guaifenesin 200 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
  • 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
Principal Display Panel 177 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 177 ml Bottle Label)

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)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)