XL-3 Xtreme
XL-3 Xtreme is an FDA drug label for the active ingredient ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE manufactured by AptaPharma Inc. administered by ORAL. 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 20231230.
- Generic name
- ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE
- Manufacturer
- AptaPharma Inc.
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 76281-305
- Application
- M012
- Label effective
- 20231230
Active ingredients
Indications & Usage
Use temporarily relieves cold/flu symptoms: • sore throat headache • minor aches and pain • fever • runny nose and sneezing • cough due to minor throat and bronchial irritation
Dosage & Administration
Directions • take only as recommended-see Overdose warning • Use dose cup or tablespoon (TBSP) • do not exceed 4 doses per 24 hours • if taking Night Time at night and Day Time during the day, limit total to 4 doses per 24 hours. adults & children 12 years and over 30 mL (2 TBSP) every 6 hours children 4 to under 12 years ask a doctor children under 4 years do not use
Contraindications
Not available.
Warnings
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 4,000 mg of acetaminophen in 24 hours • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this 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. Sore throat warning : If sore throat is severe, persists for more than two days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Adverse Reactions
Not available.