Drugplain

topcare nite time cold and flu relief 650 mg/30mL

Acetaminophen, Dextromethorphan HBr, Doxylamine succinate · SOLUTION · Topco Associates LLC

No Recall HistoryCurrently in Shortage
Plain English

topcare nite time cold and flu relief is a solution containing acetaminophen, dextromethorphan hbr, doxylamine succinate at 650 mg/30mL, taken oral. Manufactured by Topco Associates LLC.

Key Facts

Brand Name
topcare nite time cold and flu relief
Generic Name
Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
NDC Code (Product)
36800-335
Manufacturer
Topco Associates LLC
Strength
650 mg/30mL
Dosage Form
SOLUTION
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
08/18/2011

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves common cold/flu symptoms: • cough due to minor throat and bronchial irritation • sore throat • headache • minor aches and pains • fever • runny nose and sneezing

Dosage & Administration

Directions • take only as directed – see Overdose warning • only use the dose cup provided • do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL every 6 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use

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 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. 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. • if you have ever had an allergic reaction to this product

Frequently Asked Questions

What is topcare nite time cold and flu relief used for?

topcare nite time cold and flu relief contains Acetaminophen, Dextromethorphan HBr, Doxylamine succinate. It is a solution taken oral. Consult your doctor for specific uses.

Is topcare nite time cold and flu relief a controlled substance?

topcare nite time cold and flu relief is not classified as a controlled substance by the DEA.

What is the generic name for topcare nite time cold and flu relief?

The generic name for topcare nite time cold and flu relief is Acetaminophen, Dextromethorphan HBr, Doxylamine succinate. There are 11 other brand versions of Acetaminophen, Dextromethorphan HBr, Doxylamine succinate.

What is the NDC code for topcare nite time cold and flu relief 650 mg/30mL?

The NDC (National Drug Code) for topcare nite time cold and flu relief 650 mg/30mL is 36800-335, listed by Topco Associates LLC.