Drugplain

Nighttime Cold and Flu Multi Symptom Relief 325 mg/1

Acetaminophen, Dextromethorphan HBr, Doxylamine succinate · CAPSULE, LIQUID FILLED · Shield Pharmaceuticals Corp

No Recall HistoryCurrently in Shortage
Plain English

Nighttime Cold and Flu Multi Symptom Relief is a capsule, liquid filled containing acetaminophen, dextromethorphan hbr, doxylamine succinate at 325 mg/1, taken oral. Manufactured by Shield Pharmaceuticals Corp.

Key Facts

Brand Name
Nighttime Cold and Flu Multi Symptom Relief
Generic Name
Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
NDC Code (Product)
83059-0112
Manufacturer
Shield Pharmaceuticals Corp
Strength
325 mg/1
Dosage Form
CAPSULE, LIQUID FILLED
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
11/12/2025

Recall History

No Recall History

Side Effects Reported to FDA

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

contusion1 reports
dehydration1 reports
drug toxicity1 reports
hepatic necrosis1 reports
hepatic steatosis1 reports

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 & bronchial irritation • sore throat • headache• minor aches & pains• fever• runny nose & sneezing

Dosage & Administration

Directions • take only as directed • do not exceed 8 softgels per 24 hrs • adults & children 12 yrs & over 2 Softgels with water 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 8 Softgels in 24 hrs, which is the maximum daily amount for this product • with other drugs containing acetaminophen • 3 or more alcoholic drinks daily 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.

Frequently Asked Questions

What is Nighttime Cold and Flu Multi Symptom Relief used for?

Nighttime Cold and Flu Multi Symptom Relief contains Acetaminophen, Dextromethorphan HBr, Doxylamine succinate. It is a capsule, liquid filled taken oral. Consult your doctor for specific uses.

Is Nighttime Cold and Flu Multi Symptom Relief a controlled substance?

Nighttime Cold and Flu Multi Symptom Relief is not classified as a controlled substance by the DEA.

What is the generic name for Nighttime Cold and Flu Multi Symptom Relief?

The generic name for Nighttime Cold and Flu Multi Symptom Relief is Acetaminophen, Dextromethorphan HBr, Doxylamine succinate. There are 12 other brand versions of Acetaminophen, Dextromethorphan HBr, Doxylamine succinate.

What is the NDC code for Nighttime Cold and Flu Multi Symptom Relief 325 mg/1?

The NDC (National Drug Code) for Nighttime Cold and Flu Multi Symptom Relief 325 mg/1 is 83059-0112, listed by Shield Pharmaceuticals Corp.