Drug Facts

Drug Facts
SPL v9
SPL
SPL Set ID ac8c0c15-b305-47f2-8712-e4b53636f7fa
Route
ORAL
Published
Effective Date 2019-03-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (400 mg) Dextromethorphan (20 mg)
Inactive Ingredients
Magnesium Stearate Maltodextrin Cellulose, Microcrystalline Povidone, Unspecified Silicon Dioxide Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: PH073 Shape: capsule Color: white Size: 18 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2018-04-02 Until 2027-11-30
Description

Guaifenesin 400mg Dextromethorphan HBr 20mg

Purpose

Expectorant Cough suppressant

Medication Information

Purpose

Expectorant

Cough suppressant

Description

Guaifenesin 400mg Dextromethorphan HBr 20mg

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
  • helps make cough more productive
  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a common cold
Section 51945-4

Warnings

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 MAOI drug. If you do not know whether your prescription drug contains MAOI, ask your doctor or pharmacist before using this product.
Directions
  • take with a full glass of water
  • this product can be administered without regard for the timing of meals
  • do not exceed 6 doses in 24 hours or as directed by doctor

adults and children 12 years of age and over

take 1 tablet every 4 hours as needed

children 6 to under 12 years of age

take ½ tablet every 4 hours as needed

children under 6 years of age

consult a doctor

Questions?

Adverse drug event call (866) 562-2756

Other Information
  • store at room temperature 15°-30°C (59°-86°F)
Inactive Ingredients

magnesium stearate, maltodextrin, microcrystalline celluclose, povidone, silicon dioxide, stearic acid.

When Using This Product
  • do not use more than directed
Stop Use and Ask A Doctor If
  • cough lasts more than 7 days, comes back, or occure with fever, rash or persistent headache

These could be signs of serious illness.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Active Ingredients (in Each Tablet)

Guaifenesin 400mg

Dextromethorphan HBr 20mg

Ask A Doctor Before Use If You Have
  • persistent or chronic cough, such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough accompanied by too much phlegm (mucus)

Structured Label Content

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
  • helps make cough more productive
  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a common cold
Section 51945-4 (51945-4)

Purpose

Expectorant

Cough suppressant

Warnings

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 MAOI drug. If you do not know whether your prescription drug contains MAOI, ask your doctor or pharmacist before using this product.
Directions
  • take with a full glass of water
  • this product can be administered without regard for the timing of meals
  • do not exceed 6 doses in 24 hours or as directed by doctor

adults and children 12 years of age and over

take 1 tablet every 4 hours as needed

children 6 to under 12 years of age

take ½ tablet every 4 hours as needed

children under 6 years of age

consult a doctor

Questions?

Adverse drug event call (866) 562-2756

Other Information (Other information)
  • store at room temperature 15°-30°C (59°-86°F)
Inactive Ingredients (Inactive ingredients)

magnesium stearate, maltodextrin, microcrystalline celluclose, povidone, silicon dioxide, stearic acid.

When Using This Product (When using this product)
  • do not use more than directed
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • cough lasts more than 7 days, comes back, or occure with fever, rash or persistent headache

These could be signs of serious illness.

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

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Active Ingredients (in Each Tablet) (Active ingredients (in each tablet))

Guaifenesin 400mg

Dextromethorphan HBr 20mg

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 accompanied by too much phlegm (mucus)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:01:18.368535 · Updated: 2026-03-14T23:01:21.342577