Drugplain

TopCare Nite Time SEVERE Cold and Flu 325 mg/1

Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride · CAPSULE, LIQUID FILLED · Topco Associates LLC

No Recall HistoryCurrently in Shortage
Plain English

Topcare Nite Time Severe Cold and Flu is an over-the-counter medicine available as a liquid-filled capsule that combines a pain reliever and fever reducer (acetaminophen), a cough suppressant (dextromethorphan), a sleep aid (doxylamine), and a nasal decongestant (phenylephrine) to help relieve multiple nighttime cold and flu symptoms. This combination product is designed to help you sleep while treating cough, congestion, aches, and fever associated with colds and the

Key Facts

Brand Name
TopCare Nite Time SEVERE Cold and Flu
Generic Name
Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride
NDC Code (Product)
76162-812
Manufacturer
Topco Associates LLC
Strength
325 mg/1
Dosage Form
CAPSULE, LIQUID FILLED
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
11/03/2023

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

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 4 hours 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 hours, which is the maximum daily amount for this product • 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 • 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. Ask a doctor before use …

Frequently Asked Questions

What is TopCare Nite Time SEVERE Cold and Flu used for?

Topcare Nite Time Severe Cold and Flu is an over-the-counter medicine available as a liquid-filled capsule that combines a pain reliever and fever reducer (acetaminophen), a cough suppressant (dextromethorphan), a sleep aid (doxylamine), and a nasal decongestant (phenylephrine) to help relieve multiple nighttime cold and flu symptoms. This combination product is designed to help you sleep while treating cough, congestion, aches, and fever associated with colds and the

Is TopCare Nite Time SEVERE Cold and Flu a controlled substance?

TopCare Nite Time SEVERE Cold and Flu is not classified as a controlled substance by the DEA.

What is the generic name for TopCare Nite Time SEVERE Cold and Flu?

The generic name for TopCare Nite Time SEVERE Cold and Flu is Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride. There are 12 other brand versions of Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride.

What is the NDC code for TopCare Nite Time SEVERE Cold and Flu 325 mg/1?

The NDC (National Drug Code) for TopCare Nite Time SEVERE Cold and Flu 325 mg/1 is 76162-812, listed by Topco Associates LLC.

Product NDC

76162-812

Package NDC

76162-812-24

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

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