vicks ®

vicks ®
SPL v1
SPL
SPL Set ID 3258067b-8e32-2b4a-e063-6394a90a7433
Route
oral
Published
Effective Date 2025-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dextromethorphan (20 mg) guaifenesin (400 mg)
Inactive Ingredients
sodium chloride glycerin sodium benzoate sorbitol xanthan gum propylene glycol water saccharin sodium fd&c red no. 40 citric acid d&c yellow no. 10 fd&c green no. 3 fd&c yellow no. 6 sucralose trisodium citrate dihydrate

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
otc monograph drug active Since 2025-07-01
Purpose

Cough suppressant Expectorant

Description

Drug Facts

Medication Information

Uses
  • temporarily relieves common cold symptoms:

• cough due to minor throat & bronchial irritation

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs

more productive.

Purpose

Cough suppressant

Expectorant

Directions

• take only as directed

• only use the dose cup provided

• do not exceed 6 doses per 24 hours

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

Other Information

• each 15 mL contains: sodium 46 mg

• store at no greater than 25°C

Inactive Ingredients

anhydrous citric acid, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, FD&C Yellow No. 6, flavor, glycerin, propylene glycol, saccharin sodium, sodium benzoate, sodium chloride, sorbitol, sucralose, trisodium citrate dihydrate, water, xanthan gum

Description

Drug Facts

Questions?

1-800-362-1683

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

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.

Stop Use and Ask A Doctor If
  • 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)



Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Ask A Doctor Before Use If You Have
  • 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 354 Ml Bottle Label

VICKS®

FORMULA 44DM

HONEY COUGH & CONGESTION

Dextromethorphan HBr

Guaifenesin

Cough

Chest Congestion, Thins & Loosens Mucus

12 FL OZ (354 mL)

Structured Label Content

Uses
  • temporarily relieves common cold symptoms:

• cough due to minor throat & bronchial irritation

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs

more productive.

Purpose

Cough suppressant

Expectorant

Directions

• take only as directed

• only use the dose cup provided

• do not exceed 6 doses per 24 hours

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

Other Information (Other information)

• each 15 mL contains: sodium 46 mg

• store at no greater than 25°C

Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, FD&C Yellow No. 6, flavor, glycerin, propylene glycol, saccharin sodium, sodium benzoate, sodium chloride, sorbitol, sucralose, trisodium citrate dihydrate, water, xanthan gum

Questions?

1-800-362-1683

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

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.

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



Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • 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 354 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 354 ml Bottle Label)

VICKS®

FORMULA 44DM

HONEY COUGH & CONGESTION

Dextromethorphan HBr

Guaifenesin

Cough

Chest Congestion, Thins & Loosens Mucus

12 FL OZ (354 mL)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:24.767212 · Updated: 2026-03-14T23:09:10.710567