Nighttime Severe Cold and Cough 650 mg/30mL

Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl · LIQUID · P & L Development, LLC

No Recall HistoryCurrently in Shortage

Plain English

Nighttime Severe Cold and Cough is a liquid containing acetaminophen, diphenhydramine hcl, phenylephrine hcl at 650 mg/30mL, taken oral. Manufactured by P & L Development, LLC.

Key Facts

Brand Name: Nighttime Severe Cold and Cough
Generic Name: Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
NDC Code (Product): 49580-0502
Manufacturer: P & L Development, LLC
Strength: 650 mg/30mL
Dosage Form: LIQUID
Route: ORAL
Marketing Status
Application #: M012
Marketing Start: 04/30/2021

Recall History

No Recall History

Side Effects Reported to FDA

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

drug ineffective15 reports

dyspnoea13 reports

fatigue9 reports

feeling abnormal9 reports

nasopharyngitis9 reports

nausea9 reports

anxiety8 reports

influenza8 reports

cough7 reports

headache7 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses • temporarily relieves these symptoms due to a cold: • minor aches and pains • minor sore throat pain • headache • nasal and sinus congestion • cough due to minor throat and bronchial irritation • temporarily reduces fever

Dosage & Administration

Directions • do not use more than directed (see overdose warning) • take every 4 hours, while symptoms persist. Do not take more than 6 packets in 24 hours unless directed by a doctor. Age Dose adults and children 12 years of age and over one packet children under 12 years of age do not use • dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10-15 minutes. • if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat.

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 • in a child under 12 years of age • if you have ever had an allergic reaction to this product or any of its ingredients • 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 a…

Frequently Asked Questions

What is Nighttime Severe Cold and Cough used for?

Nighttime Severe Cold and Cough contains Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl. It is a liquid taken oral. Consult your doctor for specific uses.

Is Nighttime Severe Cold and Cough a controlled substance?

Nighttime Severe Cold and Cough is not classified as a controlled substance by the DEA.

What is the generic name for Nighttime Severe Cold and Cough?

The generic name for Nighttime Severe Cold and Cough is Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl. There are 11 other brand versions of Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl.

What is the NDC code for Nighttime Severe Cold and Cough 650 mg/30mL?

The NDC (National Drug Code) for Nighttime Severe Cold and Cough 650 mg/30mL is 49580-0502, listed by P & L Development, LLC.

Product NDC

49580-0502

Package NDC

49580-0502-8

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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)