MAXIMUM STRENGTH Sinus Relief

MAXIMUM STRENGTH Sinus Relief is an FDA drug label for the active ingredient ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE manufactured by Topco Associates LLC. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231229.

Generic: ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE

Manufacturer: Topco Associates LLC

Product Type: HUMAN OTC DRUG

Route:

Dosage Form:

NDC: 76162-824

Application: M012

Effective: 20231229

Active Ingredients: Active ingredients (in each softgel) DAY Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mgActive ingredients (in each softgel) NIGHT Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg Phenylephrine HCl 5 mg

Indications & Usage

Uses • temporarily relieves: • nasal congestion • headache • cough • minor aches & pains • sinus congestion & pressure • temporarily promotes nasal and/or sinus drainage • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Dosage & Administration

Directions • do not take more than directed (see Overdose warning) • do not take more than 12 softgels in any 24-hour period • adults and children 12 years of age and older: take 2 softgels every 4 hours • children under 12 years of age: do not use

Contraindications

Not available.

Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: • more than 12 softgels in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using these product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash If a skin reaction occurs, stop use and seek medical help right away. Do not use • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • 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 • liver disease • heart disease • diabetes • high blood pressure • thyroid disease • trouble urinating due to enlarged prostate gland • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema • cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are • taking the blood thinning drug warfarin When using these products • do not use more than directed. Stop use and ask a doctor if • nervousness, dizziness or sleeplessness occur • pain, nasal congestion, or cough gets worse or lasts more than 7 days • fever gets worse or lasts more than 3 days • redness or swelling is present • new symptoms occur • cough comes back or occurs with rash or headache that lasts. 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. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away.

Adverse Reactions