Nighttime Severe Cold and Cough 650 mg/1
ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE · POWDER, FOR SOLUTION · RARITAN PHARMACEUTICALS INC
Nighttime Severe Cold and Cough is an over-the-counter powder medication that combines acetaminophen (a pain reliever and fever reducer), diphenhydramine (a sleep-aid antihistamine), and phenylephrine (a decongestant) to relieve multiple cold and cough symptoms, especially at night. You mix the powder with water to drink it.
Key Facts
- Brand Name
- Nighttime Severe Cold and Cough
- Generic Name
- ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE
- NDC Code (Product)
68163-541- Manufacturer
- RARITAN PHARMACEUTICALS INC
- Strength
- 650 mg/1
- Dosage Form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Marketing Status
- Application #
- M012
- Marketing Start
- 03/22/2019
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
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 is an over-the-counter powder medication that combines acetaminophen (a pain reliever and fever reducer), diphenhydramine (a sleep-aid antihistamine), and phenylephrine (a decongestant) to relieve multiple cold and cough symptoms, especially at night. You mix the powder with water to drink it.
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 68163-541, listed by RARITAN PHARMACEUTICALS INC.