Drug Facts
d38d627e-441f-49f6-b05d-75750944e97d
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
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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Additional Information
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Source: dailymed · Ingested: 2026-02-15T11:56:28.639613 · Updated: 2026-03-14T22:54:57.914892