Vicks ®

Vicks ®
SPL v6
SPL
SPL Set ID 05412b91-c1f0-c947-e063-6294a90acd17
Route
ORAL
Published
Effective Date 2025-12-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg) Guaifenesin (200 mg)
Inactive Ingredients
Sodium Benzoate Sucralose Xanthan Gum Sodium Chloride Sorbitol Citric Acid Monohydrate Fd&c Red No. 40 Propylene Glycol Water Glycerin Saccharin Sodium Sodium Citrate

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-12-21

Description

Drug Facts

Purpose

Cough suppressant Expectorant


Medication Information

Purpose

Cough suppressant

Expectorant

Description

Drug Facts

Uses
  • temporarily relieves cough due to minor throat and bronchial irritation associated with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
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.

Section 50570-1

Do not useif 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.

Directions

• take only as directed

• only use the dose cup provided

• do not exceed 6 doses per 24 hours

adults and children 12 years and over 30 mL every 4 hours
children 6 to under 12 years 15 mL every 4 hours
children 4 to under 6 years ask a doctor
children under 4 years do not use

Questions?

1-800-362-1683

Other Information

• each 15 mL contains:sodium 45 mg

• store at no greater than 25°C

Inactive Ingredients

citric acid, FD&C Red No. 40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, xanthan gum

Stop Use and Ask A Doctor If

cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Active Ingredient (in Each 15 Ml)

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Ask A Doctor Before Use If You Have
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)
  • a sodium-restricted diet
Principal Display Panel 354 Ml Bottle Label

VICKS ®

FORMULA 44™ DM

COUGH &

CHEST CONGESTION

Dextromethorphan HBr, Guaifenesin

Cough

Chest Congestion, Thins & Loosens Mucus

Non-Drowsy

12 FL OZ (354 ml)


Structured Label Content

Uses
  • temporarily relieves cough due to minor throat and bronchial irritation associated with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
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.

Section 50570-1 (50570-1)

Do not useif 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.

Purpose

Cough suppressant

Expectorant

Directions

• take only as directed

• only use the dose cup provided

• do not exceed 6 doses per 24 hours

adults and children 12 years and over 30 mL every 4 hours
children 6 to under 12 years 15 mL every 4 hours
children 4 to under 6 years ask a doctor
children under 4 years do not use

Questions?

1-800-362-1683

Other Information (Other information)

• each 15 mL contains:sodium 45 mg

• store at no greater than 25°C

Inactive Ingredients (Inactive ingredients)

citric acid, FD&C Red No. 40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, xanthan gum

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

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

ask a health professional before use.

Active Ingredient (in Each 15 Ml) (Active ingredient (in each 15 mL))

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)
  • a sodium-restricted diet
Principal Display Panel 354 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 354 ml Bottle Label)

VICKS ®

FORMULA 44™ DM

COUGH &

CHEST CONGESTION

Dextromethorphan HBr, Guaifenesin

Cough

Chest Congestion, Thins & Loosens Mucus

Non-Drowsy

12 FL OZ (354 ml)


Advanced Ingredient Data


Raw Label Data

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