Drugplain

Nighttime Severe Cold and Cough 650 mg/1

ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE · POWDER, FOR SOLUTION · KROGER COMPANY

No Recall HistoryCurrently in Shortage
Plain English

Nighttime Severe Cold and Cough is a powder, for solution containing acetaminophen, diphenhydramine, phenylephrine at 650 mg/1, taken oral. Manufactured by KROGER COMPANY.

Key Facts

Brand Name
Nighttime Severe Cold and Cough
Generic Name
ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE
NDC Code (Product)
41226-541
Manufacturer
KROGER COMPANY
Strength
650 mg/1
Dosage Form
POWDER, FOR SOLUTION
Route
ORAL
Marketing Status
Application #
M010
Marketing Start
01/15/2024

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, PHENYLEPHRINE. It is a powder, for solution 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, PHENYLEPHRINE. There are 3 other brand versions of ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE.

What is the NDC code for Nighttime Severe Cold and Cough 650 mg/1?

The NDC (National Drug Code) for Nighttime Severe Cold and Cough 650 mg/1 is 41226-541, listed by KROGER COMPANY.

Product NDC

41226-541

Package NDC

41226-541-06

Other Nighttime Severe Cold and Cough Dosages

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

Data from openFDA · Public domain (CC0 1.0)