Alka-Seltzer Plus Cold Day and Night ASPIRIN DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHRINE BITARTRATE DOXYLAMINE SUCCINATE BAYER HEALTHCARE LLC. FDA Approved Uses •temporarily relieves these symptoms due to a cold with cough:  • minor aches and pains  • headache  • cough  • nasal and sinus congestion  • sore throat  • temporarily reduces fever Uses Uses  • temporarily relieves these symptoms due to a cold:  • minor aches and pains  • headache  • runny nose  • sinus congestion and pressure  • cough  • sneezing  • sore throat  • nasal congestion  • temporarily reduces fever
FunFoxMeds box
Route
ORAL
Applications
M012
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each tablet) Aspirin 325 mg (NSAID)* Dextromethorphan hydrobromide 10 mg Phenylephrine bitartrate 7.8 mg *nonsteroidal anti-inflammatory drug Active ingredients (in each tablet) Aspirin 500 mg (NSAID)* Dextromethorphan hydrobromide 10 mg Doxylamine succinate 6.25 mg Phenylephrine bitartrate 7.8 mg *nonsteroidal anti-inflammatory drug
Inactive Ingredients
Inactive ingredients acesulfame potassium anhydrous citric acid aspartame calcium silicate dimethicone docusate sodium flavors mannitol povidone sodium benzoate sodium bicarbonate Inactive ingredients acesulfame potassium anhydrous citric acid aspartame calcium silicate dimethicone docusate sodium flavors (natural & artificial) mannitol povidone sodium benzoate sodium bicarbonate
Strengths
325 mg 10 mg 7.8 mg 500 mg 6.25 mg
Treats Conditions
Uses Temporarily Relieves These Symptoms Due To A Cold With Cough Minor Aches And Pains Headache Cough Nasal And Sinus Congestion Sore Throat Temporarily Reduces Fever Uses Uses Temporarily Relieves These Symptoms Due To A Cold Minor Aches And Pains Headache Runny Nose Sinus Congestion And Pressure Cough Sneezing Sore Throat Nasal Congestion Temporarily Reduces Fever
Pill Appearance
Shape: round Color: white Imprint: ASP;NT

Identifiers & Packaging

Container Type BOX
All Product Codes
UPC
0016500572633
Packaging

Package Display Label Alka-Seltzer PLUS® DAY NON-DROWSY ASPIRIN (NSAID) / Pain Reliever-Fever Reducer Dextromethorphan HBr / Cough Suppressant Phenylephrine Bitartrate / Nasal Decongestant Nasal Congestion Headache & Body Ache Cough Sore Throat Sinus Pressure 12 EFFERVESCENT TABLETS NIGHT ASPIRIN (NSAID) / Pain Reliever-Fever Reducer Dextromethorphan HBr / Cough Suppressant Doxylamine Succinate / Antihistamine Phenylephrine Bitartrate / Nasal Decongestant Nasal Congestion Headache & Body Ache Cough Runny nose Sore Throat 8 EFFERVESCENT TABLETS PDP PDP Carton label

Package Descriptions
  • Package Display Label Alka-Seltzer PLUS® DAY NON-DROWSY ASPIRIN (NSAID) / Pain Reliever-Fever Reducer Dextromethorphan HBr / Cough Suppressant Phenylephrine Bitartrate / Nasal Decongestant Nasal Congestion Headache & Body Ache Cough Sore Throat Sinus Pressure 12 EFFERVESCENT TABLETS NIGHT ASPIRIN (NSAID) / Pain Reliever-Fever Reducer Dextromethorphan HBr / Cough Suppressant Doxylamine Succinate / Antihistamine Phenylephrine Bitartrate / Nasal Decongestant Nasal Congestion Headache & Body Ache Cough Runny nose Sore Throat 8 EFFERVESCENT TABLETS PDP PDP Carton label

Overview

Uses •temporarily relieves these symptoms due to a cold with cough:  • minor aches and pains  • headache  • cough  • nasal and sinus congestion  • sore throat  • temporarily reduces fever Uses Uses  • temporarily relieves these symptoms due to a cold:  • minor aches and pains  • headache  • runny nose  • sinus congestion and pressure  • cough  • sneezing  • sore throat  • nasal congestion  • temporarily reduces fever

Indications & Usage

Uses •temporarily relieves these symptoms due to a cold with cough:  • minor aches and pains  • headache  • cough  • nasal and sinus congestion  • sore throat  • temporarily reduces fever Uses Uses  • temporarily relieves these symptoms due to a cold:  • minor aches and pains  • headache  • runny nose  • sinus congestion and pressure  • cough  • sneezing  • sore throat  • nasal congestion  • temporarily reduces fever

Dosage & Administration

Directions Directions ● adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water every 4 hours. Do not exceed 8 tablets in 24 hours or as directed by a doctor. ● children under 12 years: do not use Directions Directions ● adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water at bedtime (may be taken every 4 to 6 hours). Do not exceed 8 tablets in 24 hours or as directed by a doctor. ● children under 12 years: do not use

Warnings & Precautions
Warnings Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness. Allergy alert: Aspirin may cause a severe allergic reaction which may include:  ● hives  ● facial swelling  ● asthma (wheezing)  ● shock Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you ● are age 60 or older ● have had stomach ulcers or bleeding problems ● take a blood thinning (anticoagulant) or steroid drug ● take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) ● have 3 or more alcoholic drinks every day while using this product ● take more or for a longer time than directed 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. Warnings Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness. Allergy alert: Aspirin may cause a severe allergic reaction which may include: ● hives  ● facial swelling  ● asthma (wheezing)  ● shock Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you ● are age 60 or older ● have had stomach ulcers or bleeding problems ● take a blood thinning (anticoagulant) or steroid drug ● take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) ● have 3 or more alcoholic drinks every day while using this product ● take more or for a longer time than directed 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 Nasal decongestant Purposes Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant

Do Not Use

Do not use ● if you are allergic to aspirin or any other pain reliever/fever reducer ● 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 Do not use ● if you are allergic to aspirin or any other pain reliever/fever reducer ● 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 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 ● an allergic reaction occurs. Seek medical help right away. ● you experience any of the following signs of stomach bleeding ● feel faint ● vomit blood ● have bloody or black stools ● have stomach pain that does not get better ● 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  ● ringing in the ears or loss of hearing occurs  ● cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.  ● nervousness, dizziness, or sleeplessness occurs Stop use and ask a doctor if ● an allergic reaction occurs. Seek medical help right away. ● you experience any of the following signs of stomach bleeding ● feel faint ● vomit blood ● have bloody or black stools ● have stomach pain that does not get better ● 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 ● ringing in the ears or loss of hearing occurs ● 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. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Questions

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


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