Drugplain

Ultra Concentrated Nighttime COLD AND FLU 325 mg/1

acetaminophen, dextromethorphan hydrobromide, doxylamine succinate · CAPSULE, LIQUID FILLED · PuraCap Pharmaceutical LLC

No Recall HistoryCurrently in Shortage
Plain English

Ultra Concentrated Nighttime COLD AND FLU is a capsule, liquid filled containing acetaminophen, dextromethorphan hydrobromide, doxylamine succinate at 325 mg/1, taken oral. Manufactured by PuraCap Pharmaceutical LLC.

Key Facts

Brand Name
Ultra Concentrated Nighttime COLD AND FLU
Generic Name
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate
NDC Code (Product)
51013-668
Manufacturer
PuraCap Pharmaceutical LLC
Strength
325 mg/1
Dosage Form
CAPSULE, LIQUID FILLED
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
03/12/2025

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

suspected suicide1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever runny nose & sneezing

Dosage & Administration

Directions take only as directed - see Overdose warning do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 2 softgels with water every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use when using other Nighttime or Daytime products, carefully read each label to ensure correct dosing

Warnings

Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 4 doses in 24 hrs, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product Sore throat warning If sore throat is severe, lasts more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly. 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. 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. to make a child sleep Ask a doctor before use if you have liv…

Frequently Asked Questions

What is Ultra Concentrated Nighttime COLD AND FLU used for?

Ultra Concentrated Nighttime COLD AND FLU contains acetaminophen, dextromethorphan hydrobromide, doxylamine succinate. It is a capsule, liquid filled taken oral. Consult your doctor for specific uses.

Is Ultra Concentrated Nighttime COLD AND FLU a controlled substance?

Ultra Concentrated Nighttime COLD AND FLU is not classified as a controlled substance by the DEA.

What is the generic name for Ultra Concentrated Nighttime COLD AND FLU?

The generic name for Ultra Concentrated Nighttime COLD AND FLU is acetaminophen, dextromethorphan hydrobromide, doxylamine succinate. There are 12 other brand versions of acetaminophen, dextromethorphan hydrobromide, doxylamine succinate.

What is the NDC code for Ultra Concentrated Nighttime COLD AND FLU 325 mg/1?

The NDC (National Drug Code) for Ultra Concentrated Nighttime COLD AND FLU 325 mg/1 is 51013-668, listed by PuraCap Pharmaceutical LLC.

Product NDC

51013-668

Package NDC

51013-668-01

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)