Drugplain

Nite-Time COLD/FLU ORIGINAL 650 mg/30mL

ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE · LIQUID · Salado Sales, Inc.

No Recall HistoryCurrently in Shortage
Plain English

Nite-Time Cold/Flu Original is an over-the-counter liquid medicine taken by mouth that contains acetaminophen to reduce fever and pain, dextromethorphan to relieve cough, and doxylamine succinate to help with sleep. It's designed to provide nighttime relief from common cold and flu symptoms.

Key Facts

Brand Name
Nite-Time COLD/FLU ORIGINAL
Generic Name
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
NDC Code (Product)
57243-501
Manufacturer
Salado Sales, Inc.
Strength
650 mg/30mL
Dosage Form
LIQUID
Route
ORAL
Marketing Status
Application #
M013
Marketing Start
01/16/2012

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

suspected suicide1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

Directions take only as recommended-see Overdose warnings Use dose cup or tablespoon (TBSP) do not exceed 4 doses per 24 hours If taking Nite Time at night and Day Time during the day, limit total to 4 doses per 24 hours AptaPharma NiteTime2 Label

Warnings

Warnings Failure to follow these warnings could result in serious consequences Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4 doses in 24 hours, which is the maximum daily amoun 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 ccurs, 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.

Frequently Asked Questions

What is Nite-Time COLD/FLU ORIGINAL used for?

Nite-Time Cold/Flu Original is an over-the-counter liquid medicine taken by mouth that contains acetaminophen to reduce fever and pain, dextromethorphan to relieve cough, and doxylamine succinate to help with sleep. It's designed to provide nighttime relief from common cold and flu symptoms.

Is Nite-Time COLD/FLU ORIGINAL a controlled substance?

Nite-Time COLD/FLU ORIGINAL is not classified as a controlled substance by the DEA.

What is the generic name for Nite-Time COLD/FLU ORIGINAL?

The generic name for Nite-Time COLD/FLU ORIGINAL is ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE. There are 12 other brand versions of ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE.

What is the NDC code for Nite-Time COLD/FLU ORIGINAL 650 mg/30mL?

The NDC (National Drug Code) for Nite-Time COLD/FLU ORIGINAL 650 mg/30mL is 57243-501, listed by Salado Sales, Inc..