Drugplain

Cold Multi-Symptom Night-time 325 mg/1

Acetaminophen,Chlorpheniramine maleate, Dextromethorphan HBr and Phenylephrine HCI · TABLET · Allegiant Health

No Recall History
Plain English

This over-the-counter tablet combines acetaminophen (a pain reliever and fever reducer), chlorpheniramine (an antihistamine), dextromethorphan (a cough suppressant), and phenylephrine (a decongestant) to treat multiple cold symptoms including aches, fever, cough, and nasal congestion, particularly for nighttime use. You can purchase this medication without a prescription at pharmacies and other retail locations.

Key Facts

Brand Name
Cold Multi-Symptom Night-time
Generic Name
Acetaminophen,Chlorpheniramine maleate, Dextromethorphan HBr and Phenylephrine HCI
NDC Code (Product)
69168-319
Manufacturer
Allegiant Health
Strength
325 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
HUMAN OTC DRUG
Application #
M013
Drug Class
Adrenergic alpha1-Agonists [MoA]; Histamine H1 Receptor Antagonists [MoA]
Marketing Start
12/23/2014

Recall History

No Recall History

Side Effects Reported to FDA

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

nasopharyngitis1 reports
oral herpes1 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 nasal congestion cough sneezing and runny nose sinus congestion and pressure helps clear nasal passages relieves cough to help you sleep temporarily reduces fever

Dosage & Administration

Directions do not take more than directed (see Overdose Warnings) Adults and children 12 years and over: take 2 caplets every 4 hours swallow whole; do not crush, chew or dissolve do not take more than a total of 10 caplets in 24 hours Children under 12 years: ask a doctor

Warnings

Warnings Liver warning/Allergy alert Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product with other drugs containing acetaminophen 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 immediately Sore throat warning 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

Frequently Asked Questions

What is Cold Multi-Symptom Night-time used for?

This over-the-counter tablet combines acetaminophen (a pain reliever and fever reducer), chlorpheniramine (an antihistamine), dextromethorphan (a cough suppressant), and phenylephrine (a decongestant) to treat multiple cold symptoms including aches, fever, cough, and nasal congestion, particularly for nighttime use. You can purchase this medication without a prescription at pharmacies and other retail locations.

Is Cold Multi-Symptom Night-time a controlled substance?

Cold Multi-Symptom Night-time is not classified as a controlled substance by the DEA.

What is the generic name for Cold Multi-Symptom Night-time?

The generic name for Cold Multi-Symptom Night-time is Acetaminophen,Chlorpheniramine maleate, Dextromethorphan HBr and Phenylephrine HCI. There are no other listed brand versions of Acetaminophen,Chlorpheniramine maleate, Dextromethorphan HBr and Phenylephrine HCI.

What is the NDC code for Cold Multi-Symptom Night-time 325 mg/1?

The NDC (National Drug Code) for Cold Multi-Symptom Night-time 325 mg/1 is 69168-319, listed by Allegiant Health.

Product NDC

69168-319

Package NDC

69168-319-86

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

Data from openFDA · Public domain (CC0 1.0)