Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID d38d627e-441f-49f6-b05d-75750944e97d
Route
ORAL
Published
Effective Date 2017-12-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (28 1) Guaifenesin (388 1) Phenylephrine (10 1)
Inactive Ingredients
Hypromelloses Maltodextrin Cellulose, Microcrystalline Polyethylene Glycol 3350 Povidone Sodium Starch Glycolate Type A Corn Stearic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-05-04

Description

Active Ingredients(in each tablet): Guaifenesin 388 mg, dextromethorphan hydrobromide 28 mg, phenylephrine hydrochloride 10 mg


Medication Information

Warnings and Precautions

Warning • Do not use if you are 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 if you have • diabetes • heart disease • Thyroid disease • high blood pressure • trouble urinating due to an enlarged prostate gland • cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.

When using this product do not use more than directed.

Stop use and ask a doctor if • nervousness, dizziness or sleeplessness occur • symptoms do not get better within 7 days or are accompanied by fever • coughs lasts more than 7 days, comes back, or is accompanied by fever, rash, or a persistent headache. These could be signs of a serious condition.

Indications and Usage

Uses • temporarily relieves cough due to minor throat or bronchial irritation associated with a cold or inhaled irritants • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus, drain bronchial tubes, and make coughs more productive • temporarily relieves nasal congestion due to a cold, hay fever or other respiratory allergies, reduces swelling of nasal passages; shrinks swollen membranes

Dosage and Administration

Directions • do not exceed recommended doses in a 24 hour period.

• Adults and Children 12 years of age and over. 1 tablet every 6-8 hours. Do not exceed 4 tablets in 24 hours.

• Children 6 to under 12 years of age: 1⁄2 tablet every 6-8 hours.  Do not exceed 2 tablets in 24 hours.

• Children under 6 years of age: ask physician.

Description

Active Ingredients(in each tablet): Guaifenesin 388 mg, dextromethorphan hydrobromide 28 mg, phenylephrine hydrochloride 10 mg

Section 50565-1

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Section 51727-6

Inactive ingredients

Hypromellose Maltodextrin, Microcrystalline Cellulose, Polyethylene Glycol / Macrogol, Povidone, Sodium Starch Glycolate, Stearic Acid

Section 53414-9

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

Section 55105-1

Cough Suppressant, Expectorant, Nasal Decongestant

Section 55106-9

Active Ingredients(in each tablet): Guaifenesin 388 mg, dextromethorphan hydrobromide 28 mg, phenylephrine hydrochloride 10 mg

Packaging


Structured Label Content

Indications and Usage (34067-9)

Uses • temporarily relieves cough due to minor throat or bronchial irritation associated with a cold or inhaled irritants • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus, drain bronchial tubes, and make coughs more productive • temporarily relieves nasal congestion due to a cold, hay fever or other respiratory allergies, reduces swelling of nasal passages; shrinks swollen membranes

Dosage and Administration (34068-7)

Directions • do not exceed recommended doses in a 24 hour period.

• Adults and Children 12 years of age and over. 1 tablet every 6-8 hours. Do not exceed 4 tablets in 24 hours.

• Children 6 to under 12 years of age: 1⁄2 tablet every 6-8 hours.  Do not exceed 2 tablets in 24 hours.

• Children under 6 years of age: ask physician.

Warnings and Precautions (34071-1)

Warning • Do not use if you are 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 if you have • diabetes • heart disease • Thyroid disease • high blood pressure • trouble urinating due to an enlarged prostate gland • cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.

When using this product do not use more than directed.

Stop use and ask a doctor if • nervousness, dizziness or sleeplessness occur • symptoms do not get better within 7 days or are accompanied by fever • coughs lasts more than 7 days, comes back, or is accompanied by fever, rash, or a persistent headache. These could be signs of a serious condition.

Section 50565-1 (50565-1)

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive ingredients

Hypromellose Maltodextrin, Microcrystalline Cellulose, Polyethylene Glycol / Macrogol, Povidone, Sodium Starch Glycolate, Stearic Acid

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Cough Suppressant, Expectorant, Nasal Decongestant

Section 55106-9 (55106-9)

Active Ingredients(in each tablet): Guaifenesin 388 mg, dextromethorphan hydrobromide 28 mg, phenylephrine hydrochloride 10 mg

Packaging


Advanced Ingredient Data


Raw Label Data

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