Cold and Flu Relief 325 mg/1

Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl · CAPSULE, LIQUID FILLED · Chain Drug Consortium, LLC

No Recall HistoryCurrently in Shortage

Plain English

Cold and Flu Relief is a capsule, liquid filled containing acetaminophen, dextromethorphan hbr, phenylephrine hcl at 325 mg/1, taken oral. Manufactured by Chain Drug Consortium, LLC.

Key Facts

Brand Name: Cold and Flu Relief
Generic Name: Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl
NDC Code (Product): 68016-797
Manufacturer: Chain Drug Consortium, LLC
Strength: 325 mg/1
Dosage Form: CAPSULE, LIQUID FILLED
Route: ORAL
Marketing Status
Application #: M012
Marketing Start: 09/02/2022

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

fatigue20,434 reports

drug ineffective18,155 reports

pain18,106 reports

nausea17,627 reports

headache16,715 reports

toxicity to various agents15,539 reports

dyspnoea14,577 reports

arthralgia14,308 reports

pyrexia14,269 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 capsule, liquid filled 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 12 other brand versions of Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl.

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

The NDC (National Drug Code) for Cold and Flu Relief 325 mg/1 is 68016-797, listed by Chain Drug Consortium, LLC.

Product NDC

68016-797

Package NDC

68016-797-16

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)