Drugplain

Cold and Flu Relief 325 mg/15mL

Acetaminophen Dextromethorphan HBr Phenylephrine HCl · LIQUID · QUALITY CHOICE (Chain Drug Marketing Association)

No Recall HistoryCurrently in Shortage
Plain English

Cold and Flu Relief is a liquid containing acetaminophen dextromethorphan hbr phenylephrine hcl at 325 mg/15mL, taken oral. Manufactured by QUALITY CHOICE (Chain Drug Marketing Association).

Key Facts

Brand Name
Cold and Flu Relief
Generic Name
Acetaminophen Dextromethorphan HBr Phenylephrine HCl
NDC Code (Product)
83324-168
Manufacturer
QUALITY CHOICE (Chain Drug Marketing Association)
Strength
325 mg/15mL
Dosage Form
LIQUID
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
07/31/2024

Recall History

No Recall History

Side Effects Reported to FDA

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

off label use22,387 reports
fatigue20,436 reports
drug ineffective18,155 reports
pain18,107 reports
nausea17,626 reports
headache16,715 reports
toxicity to various agents15,539 reports
dyspnoea14,577 reports
arthralgia14,309 reports
pyrexia14,270 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

Directions do not take more than directed (see Overdose warning) do not take more than 4 doses in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device. mL = milliliter keep dosing cup with product adults and children 12 years and over: 30 mL every 6 hours children under 12 years of age: do not use when using other Daytime or Nighttime 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 4000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks everyday 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 is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use 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. with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist Ask a doctor before use if you have liver disease glaucoma cough that occur

Frequently Asked Questions

What is Cold and Flu Relief used for?

Cold and Flu Relief contains Acetaminophen Dextromethorphan HBr Phenylephrine HCl. It is a liquid taken oral. Consult your doctor for specific uses.

Is Cold and Flu Relief a controlled substance?

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

What is the generic name for Cold and Flu Relief?

The generic name for Cold and Flu Relief is Acetaminophen Dextromethorphan HBr Phenylephrine HCl. There are 5 other brand versions of Acetaminophen Dextromethorphan HBr Phenylephrine HCl.

What is the NDC code for Cold and Flu Relief 325 mg/15mL?

The NDC (National Drug Code) for Cold and Flu Relief 325 mg/15mL is 83324-168, listed by QUALITY CHOICE (Chain Drug Marketing Association).

Product NDC

83324-168

Package NDC

83324-168-08

Other Cold and Flu Relief Dosages

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

Data from openFDA · Public domain (CC0 1.0)