Drugplain

Alka-Seltzer Plus Maximum Strength Night Cold and Flu 325 mg/1

Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride · CAPSULE, LIQUID FILLED · Bayer HealthCare LLC.

No Recall HistoryCurrently in Shortage
Plain English

Alka-Seltzer Plus Maximum Strength Night Cold and Flu is a prescription capsule, liquid filled containing acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride at 325 mg/1, taken oral. Manufactured by Bayer HealthCare LLC..

Key Facts

Brand Name
Alka-Seltzer Plus Maximum Strength Night Cold and Flu
Generic Name
Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride
NDC Code (Product)
0280-1600
Manufacturer
Bayer HealthCare LLC.
Strength
325 mg/1
Dosage Form
CAPSULE, LIQUID FILLED
Route
ORAL
Marketing Status
HUMAN OTC DRUG
Application #
M012
Drug Class
Adrenergic alpha1-Agonists [MoA]; Antihistamine [EPC]
Marketing Start
06/19/2017

Recall History

No Recall History

Side Effects Reported to FDA

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

choking12 reports
foreign body in throat6 reports
oropharyngeal pain3 reports
product use complaint3 reports
dyspnoea2 reports
foreign body in respiratory tract2 reports
retching2 reports
throat irritation2 reports
abdominal pain upper1 reports
anaphylactic reaction1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses Uses · temporarily relieves these symptoms due to a cold or flu: · minor aches and pains · headache · nasal and sinus congestion · cough · sore throat · runny nose · sneezing · temporarily reduces fever

Dosage & Administration

Directions · do not take more than the recommended dose · adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not exceed 10 capsules in 24 hours or as directed by a doctor. · children under 12 years: do not use

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 every day while using this product Allergy alert: Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include: · skin reddening · blisters · rash · hives · facial swelling · asthma (wheezing) · shock If a skin or general allergic 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 to sedate children.

Frequently Asked Questions

What is Alka-Seltzer Plus Maximum Strength Night Cold and Flu used for?

Alka-Seltzer Plus Maximum Strength Night Cold and Flu contains Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride. It is a capsule, liquid filled taken oral. Consult your doctor for specific uses.

Is Alka-Seltzer Plus Maximum Strength Night Cold and Flu a controlled substance?

Alka-Seltzer Plus Maximum Strength Night Cold and Flu is not classified as a controlled substance by the DEA.

What is the generic name for Alka-Seltzer Plus Maximum Strength Night Cold and Flu?

The generic name for Alka-Seltzer Plus Maximum Strength Night Cold and Flu is Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride. There are 12 other brand versions of Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride.

What is the NDC code for Alka-Seltzer Plus Maximum Strength Night Cold and Flu 325 mg/1?

The NDC (National Drug Code) for Alka-Seltzer Plus Maximum Strength Night Cold and Flu 325 mg/1 is 0280-1600, listed by Bayer HealthCare LLC..

Product NDC

0280-1600

Package NDC

0280-1600-20

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)