Otc - Active Ingredient
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Doxylamine Succinate 12.5 mg
The following Structured Product Label (SPL) was submitted to the FDA by Rnv Llc for the product Xl-3 Night Time (NDC 84379-444). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor/pharmacist, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Doxylamine Succinate 12.5 mg
Pain reliever/fever reducer
Cough Suppressant
Antihistamine
Uses
temporarily relieves cold/flu symptoms:
Warnings
Liver warning: This product contains acetaminophen. Sever liver damage may occur if you take
Allergy alert: Acetaminophen may cause sever skin reactions. Symptoms may include:
If skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: If sore throat is sever, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly
Do not use
Ask a doctor before use if you have
Ask a doctor or pharmacist before use
When using this product
Stop use and ask a doctor if
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
Overdose warning: Taking more than the recommended dose (overdose) may cause serious health problemas including liver damamge. In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as children even if ou do not notice any signs or symptoms.
| 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 |
Other information
Inactive ingredients: Citric acid, FD&C Blue #1, FD&C Red #40, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum
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