Alka-Seltzer Plus Maximum Strength Night Cold and Flu ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DOXYLAMINE SUCCINATE PHENYLEPHRINE HYDROCHLORIDE BAYER HEALTHCARE LLC. FDA Approved 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
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Substance Acetaminophen
Route
ORAL
Applications
M012
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each capsule) Acetaminophen 325 mg Dextromethorphan hydrobromide 10 mg Doxylamine succinate 6.25 mg Phenylephrine hydrochloride 5 mg
Inactive Ingredients
Inactive ingredients D&C yellow #10 FD&C blue #1 gelatin glycerin polyethylene glycol povidone propylene glycol purified water shellac sodium hydroxide sorbitol sorbitan solution titanium dioxide
Strengths
325 mg 10 mg 6.25 mg 5 mg
Quantities
20 count
Treats Conditions
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
Pill Appearance
Shape: oval Color: green Imprint: AS;NITE

Identifiers & Packaging

Container Type BOX
All Product Codes
UPC
0016500555278
UNII
362O9ITL9D 9D2RTI9KYH V9BI9B5YI2 04JA59TNSJ
Packaging

Alka-Selter PLUS ® MAXIMUM STRENGTH Cold & Flu NIGHT ACETAMINOPHEN /Pain Reliever-Fever Reducer Dextromethorphan Hydrobromide / Cough Suppresant Doxylamine Succinate / Antihistamine Phenylephrine HCl / Nasal Decongestant Cough Nasal Congestion Runny Nose Headache & Body Ache Sore Throat 20 LIQUID GELS (Liquid Filled Capsules) Carton 20 count

Package Descriptions
  • Alka-Selter PLUS ® MAXIMUM STRENGTH Cold & Flu NIGHT ACETAMINOPHEN /Pain Reliever-Fever Reducer Dextromethorphan Hydrobromide / Cough Suppresant Doxylamine Succinate / Antihistamine Phenylephrine HCl / Nasal Decongestant Cough Nasal Congestion Runny Nose Headache & Body Ache Sore Throat 20 LIQUID GELS (Liquid Filled Capsules) Carton 20 count

Overview

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

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 & Precautions
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.
Purpose

Purposes Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant

Do Not Use

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. ● if you have ever had an allergic reaction to this product or any of its ingredients ● in children under 12 years of age

When Using

When using this product ● do not exceed recommended dosage ● may cause marked drowsiness ● avoid alcoholic drinks ● alcohol, sedatives, and tranquilizers may increase drowsiness ● be careful when driving a motor vehicle or operating machinery ● excitability may occur, especially in children

Stop Use & Ask a Doctor

Stop use and ask a doctor if · pain, cough, or nasal congestion gets worse or lasts more than 7 days · fever gets worse or lasts more than 3 days · redness or swelling is present · new symptoms occur · cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. · nervousness, dizziness, or sleeplessness occurs

Keep Out of Reach of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Questions

Questions or comments? 1-800-986-0369 (Mon-Fri 9AM - 5PM EST)


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