Cold and Flu Nighttime Severe 325 mg/1

Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl · TABLET, FILM COATED · Lil' Drug Store Products, Inc.

No Recall HistoryCurrently in Shortage

Plain English

Cold and Flu Nighttime Severe is a tablet, film coated containing acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl at 325 mg/1, taken oral. Manufactured by Lil' Drug Store Products, Inc..

Key Facts

Brand Name: Cold and Flu Nighttime Severe
Generic Name: Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl
NDC Code (Product): 29485-5053
Manufacturer: Lil' Drug Store Products, Inc.
Strength: 325 mg/1
Dosage Form: TABLET, FILM COATED
Route: ORAL
Marketing Status
Application #: M012
Marketing Start: 10/27/2021

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses Uses temporarily relieves common cold and flu symptoms: minor aches and pains sinus congestion and pressure sore throat fever headache nasal congestion cough due to minor throat and bronchial irritation cough to help you sleep runny nose and sneezing reduces swelling of nasal passages promotes nasal and/or sinus drainage temporarily restores freer breathing through the nose

Dosage & Administration

Directions Directions do not take more than directed do not take more than 8 caplets in 24 hours adults and children 12 years and over: take 2 caplets with water every 4 hours children under 12 years: ask a doctor

Warnings

Warnings Warnings Liver warning 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 Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: blisters rash skin reddening If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning 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 Do not use 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 an MAOI, ask a doctor or pharmacist before taking this product. if you h…

Frequently Asked Questions

What is Cold and Flu Nighttime Severe used for?

Cold and Flu Nighttime Severe contains Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is Cold and Flu Nighttime Severe a controlled substance?

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

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

The generic name for Cold and Flu Nighttime Severe is Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl. There are 12 other brand versions of Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl.

What is the NDC code for Cold and Flu Nighttime Severe 325 mg/1?

The NDC (National Drug Code) for Cold and Flu Nighttime Severe 325 mg/1 is 29485-5053, listed by Lil' Drug Store Products, Inc..

Product NDC

29485-5053

Package NDC

29485-5053-6

Other Acetaminophen, Brands

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

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