Drugplain

Original Night-Time MULTI-SYMPTOM COLD/FLU RELIEF 650 mg/30mL

ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE · LIQUID · Discount Drug Mart

No Recall HistoryCurrently in Shortage
Plain English

This liquid cold and flu medicine contains acetaminophen to reduce fever and pain, dextromethorphan to suppress coughs, and doxylamine to help you sleep at night. It's available over-the-counter for oral use.

Key Facts

Brand Name
Original Night-Time MULTI-SYMPTOM COLD/FLU RELIEF
Generic Name
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
NDC Code (Product)
53943-501
Manufacturer
Discount Drug Mart
Strength
650 mg/30mL
Dosage Form
LIQUID
Route
ORAL
Marketing Status
HUMAN OTC DRUG
Application #
M012
Drug Class
Antihistamine [EPC]; Histamine Receptor Antagonists [MoA]
Marketing Start
10/21/2014

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 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 and 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

Warnings

DO NOT USE IF IMPRINTED SHRINK BRAND IS MISSING OR BROKEN Failure to follow these warnings could result in serious consequences. Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if adult/child takes: ● more than 4 doses in 24 hours, which is the maximum daily amount for this product ● with other drugs containing acetaminophen ● 3 or more alcoholic drinks everyday while using this product. Allery Alert: Acetaminophen may cause severe skin reactions. Symptoms may include: ● skin reddening ● blisters ● rash If 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.

Frequently Asked Questions

What is Original Night-Time MULTI-SYMPTOM COLD/FLU RELIEF used for?

This liquid cold and flu medicine contains acetaminophen to reduce fever and pain, dextromethorphan to suppress coughs, and doxylamine to help you sleep at night. It's available over-the-counter for oral use.

Is Original Night-Time MULTI-SYMPTOM COLD/FLU RELIEF a controlled substance?

Original Night-Time MULTI-SYMPTOM COLD/FLU RELIEF is not classified as a controlled substance by the DEA.

What is the generic name for Original Night-Time MULTI-SYMPTOM COLD/FLU RELIEF?

The generic name for Original Night-Time MULTI-SYMPTOM COLD/FLU RELIEF is ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE. There are 12 other brand versions of ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE.

What is the NDC code for Original Night-Time MULTI-SYMPTOM COLD/FLU RELIEF 650 mg/30mL?

The NDC (National Drug Code) for Original Night-Time MULTI-SYMPTOM COLD/FLU RELIEF 650 mg/30mL is 53943-501, listed by Discount Drug Mart.

Product NDC

53943-501

Package NDC

53943-501-28

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)