NiteTime SEVERE Cold and Flu Relief SOFTGELS 325 mg/1
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride · CAPSULE, LIQUID FILLED · Topco Associates LLC
NiteTime SEVERE Cold and Flu Relief SOFTGELS is a capsule, liquid filled containing acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride at 325 mg/1, taken oral. Manufactured by Topco Associates LLC.
Key Facts
- Brand Name
- NiteTime SEVERE Cold and Flu Relief SOFTGELS
- Generic Name
- Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride
- NDC Code (Product)
76162-637- Manufacturer
- Topco Associates LLC
- Strength
- 325 mg/1
- Dosage Form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Marketing Status
- Application #
- M012
- Marketing Start
- 12/11/2025
Recall History
No Recall HistoryFull Prescribing Information
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 NiteTime SEVERE Cold and Flu Relief SOFTGELS used for?
NiteTime SEVERE Cold and Flu Relief SOFTGELS contains Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride. It is a capsule, liquid filled taken oral. Consult your doctor for specific uses.
Is NiteTime SEVERE Cold and Flu Relief SOFTGELS a controlled substance?
NiteTime SEVERE Cold and Flu Relief SOFTGELS is not classified as a controlled substance by the DEA.
What is the generic name for NiteTime SEVERE Cold and Flu Relief SOFTGELS?
The generic name for NiteTime SEVERE Cold and Flu Relief SOFTGELS is Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride. There are 11 other brand versions of Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride.
What is the NDC code for NiteTime SEVERE Cold and Flu Relief SOFTGELS 325 mg/1?
The NDC (National Drug Code) for NiteTime SEVERE Cold and Flu Relief SOFTGELS 325 mg/1 is 76162-637, listed by Topco Associates LLC.
Other Acetaminophen, Brands
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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)