Dextromethorphan Hbr 20mg And Guaifenesin 400mg

Dextromethorphan Hbr 20mg And Guaifenesin 400mg
SPL v4
SPL
SPL Set ID 6878aed8-df32-19f1-e053-2991aa0a614e
Route
ORAL
Published
Effective Date 2020-02-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (400 mg) Dextromethorphan (20 mg)
Inactive Ingredients
Hypromellose, Unspecified Cellulose, Microcrystalline Sodium Starch Glycolate Type A Corn Talc Silicon Dioxide Magnesium Stearate Povidone, Unspecified Maltodextrin Stearic Acid Polyethylene Glycol 400

Identifiers & Packaging

Pill Appearance
Imprint: S55 Shape: oval Color: white Size: 16 mm Score: 2
Marketing Status
OTC MONOGRAPH FINAL Active Since 2018-02-15

Description

Dextromethorphan HBr 20mg Guaifenesin 400mg


Medication Information

Warnings and Precautions

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.

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)

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 occurs with fever, rash, or persistent headache. These could be signs of a serious condition.

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

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Indications and Usage

* temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold

* helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Dosage and Administration

* take with a full glass of water

* swallow whole; do not crush, chew or dissolve

*do not take more than 6 tablets in 24 hours

adults and children 12 years of age and over 1 tablet every 4 hours
children under 12 years of age Do not use

Description

Dextromethorphan HBr 20mg Guaifenesin 400mg

Section 50565-1

In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 51727-6

microcrystalline cellulose, sodium starch glycolate, talc, colloidal silicon dioxide,magnesium stearate, polyvinyl povidone, maltodextrin, stearic acid

* May contain hydroxypropyl methylcellulose, polyethylene glycol

Section 51945-4

Section 55105-1

Cough Suppressant

Expectorant

Section 55106-9

Dextromethorphan HBr 20mg

Guaifenesin 400mg

Section 60561-8

* store at room temperature 25°C (77°F) ; excursions permitted between 15°C - 30°C (59°F - 86°F)


Structured Label Content

Indications and Usage (34067-9)

* temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold

* helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Dosage and Administration (34068-7)

* take with a full glass of water

* swallow whole; do not crush, chew or dissolve

*do not take more than 6 tablets in 24 hours

adults and children 12 years of age and over 1 tablet every 4 hours
children under 12 years of age Do not use

Warnings and Precautions (34071-1)

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.

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)

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 occurs with fever, rash, or persistent headache. These could be signs of a serious condition.

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

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50565-1 (50565-1)

In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 51727-6 (51727-6)

microcrystalline cellulose, sodium starch glycolate, talc, colloidal silicon dioxide,magnesium stearate, polyvinyl povidone, maltodextrin, stearic acid

* May contain hydroxypropyl methylcellulose, polyethylene glycol

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Cough Suppressant

Expectorant

Section 55106-9 (55106-9)

Dextromethorphan HBr 20mg

Guaifenesin 400mg

Section 60561-8 (60561-8)

* store at room temperature 25°C (77°F) ; excursions permitted between 15°C - 30°C (59°F - 86°F)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)