dextromethorphan hbr 20mg and guaifenesin 400mg

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

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.

Active Ingredient

Dextromethorphan HBr 20mg

Guaifenesin 400mg

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 60561-8

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

Structured Label Content

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.

Active Ingredient (55106-9)

Dextromethorphan HBr 20mg

Guaifenesin 400mg

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

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 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

[{"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "400", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DEXTROMETHORPHAN", "unii": "7355X3ROTS", "classCode": "ACTIB", "strengthNumerator": "20", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A CORN", "unii": "AG9B65PV6B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE, UNSPECIFIED", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MALTODEXTRIN", "unii": "7CVR7L4A2D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

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