DOSAGE & ADMINISTRATION SECTION.


Directions adults and children 12 years and over: take tablets fully dissolved in oz of water every hours. Do not exceed tablets in 24 hours or as directed by doctor. children under 12 years of age: do not use.

INACTIVE INGREDIENT SECTION.


Inactive ingredients anhydrous citric acid, calcium silicate, dimethicone, flavors, mannitol, potassium bicarbonate, povidone, sodium bicarbonate, sucralose.

INDICATIONS & USAGE SECTION.


Uses temporarily relieves these symptoms due to cold: minor aches and pains headache runny nose sinus congestion and pressurecoughsneezingsore throatnasal congestion temporarily reduces fever. temporarily relieves these symptoms due to cold: minor aches and pains headache runny nose sinus congestion and pressurecoughsneezingsore throatnasal congestion minor aches and pains headache runny nose sinus congestion and pressure. cough. sneezing. sore throat. nasal congestion. temporarily reduces fever.

OTHER SAFETY INFORMATION.


Other information each tablet contains: potassium 78 mg; sodium 356 mg store at room temperature. Avoid excessive heat.

OTC - ACTIVE INGREDIENT SECTION.


Active ingredients (in each tablet) PurposesAspirin 325 mg (NSAID)..........................Pain reliever/fever reducerDextromethorphan hydrobromide 10 mg...............Cough suppressantDoxylamine succinate 6.25 mg....................................AntihistaminePhenylephrine bitartrate 7.8 mg...........................Nasal decongestantnonsteroidal anti-inflammatory drug.

OTC - ASK DOCTOR SECTION.


Ask doctor before use ifstomach bleeding warning applies to you you have history of stomach problems, such as heartburnyou have high blood pressure, heart disease, liver cirrhosis, or kidney diseaseyou are taking diureticyou have asthmadiabetesthyroid diseaseglaucomacough that occurs with excessive phlegm (mucus)a breathing problem such as emphysema or chronic bronchitisdifficulty in urination due to enlargement of the prostate glandpersistent or chronic cough such as occurs with smoking, asthma, or emphysemaa sodium-restricted diet stomach bleeding warning applies to you you have history of stomach problems, such as heartburnyou have high blood pressure, heart disease, liver cirrhosis, or kidney diseaseyou are taking diureticyou have asthmadiabetesthyroid diseaseglaucomacough that occurs with excessive phlegm (mucus)a breathing problem such as emphysema or chronic bronchitisdifficulty in urination due to enlargement of the prostate glandpersistent or chronic cough such as occurs with smoking, asthma, or emphysemaa sodium-restricted diet you have history of stomach problems, such as heartburn. you have high blood pressure, heart disease, liver cirrhosis, or kidney disease. you are taking diuretic. you have asthmadiabetesthyroid diseaseglaucomacough that occurs with excessive phlegm (mucus)a breathing problem such as emphysema or chronic bronchitisdifficulty in urination due to enlargement of the prostate glandpersistent or chronic cough such as occurs with smoking, asthma, or emphysemaa sodium-restricted diet asthma. diabetes. thyroid disease. glaucoma. cough that occurs with excessive phlegm (mucus). breathing problem such as emphysema or chronic bronchitis. difficulty in urination due to enlargement of the prostate gland. persistent or chronic cough such as occurs with smoking, asthma, or emphysema. sodium-restricted diet.

OTC - ASK DOCTOR/PHARMACIST SECTION.


Ask doctor or pharmacist before use if you aretaking prescription drug for goutdiabetesarthritis taking sedatives or tranquilizers taking prescription drug for goutdiabetesarthritis gout. diabetes. arthritis taking sedatives or tranquilizers.

OTC - DO NOT USE SECTION.


Do not useif you are allergic to aspirin or any other pain reliever/fever reducerif you are now taking prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinsons disease), or for weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask doctor or pharmacist before taking this productif you have ever had an allergic reaction to this product or any of its ingredientsin children under 12 years of age. if you are allergic to aspirin or any other pain reliever/fever reducer. if you are now taking prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinsons disease), or for weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION.


Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center right away.

OTC - PREGNANCY OR BREAST FEEDING SECTION.


If pregnant or breast-feeding, ask health professional before use. It is especially important not to use aspirin during the last months of pregnancy unless definitely directed to do so by doctor because it may cause problems in the unborn child or complications during delivery.

OTC - QUESTIONS SECTION.


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

OTC - STOP USE SECTION.


Stop use and ask doctor ifan 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 stoolshave stomach pain that does not get better pain, cough, or nasal congestion gets worse or lasts more than daysfever gets worse or lasts more than daysredness or swelling is presentnew symptoms occurringing in the ears or loss of hearing occurscough comes back or occurs with rash or headache that lasts. These could be signs of serious condition.nervousness, dizziness, or sleeplessness occurs. 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 stoolshave stomach pain that does not get better 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 days. fever gets worse or lasts more than 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 serious condition.. nervousness, dizziness, or sleeplessness occurs.

OTC - WHEN USING SECTION.


When using this productdo not exceed recommended dosagemay cause marked drowsinessavoid alcoholic drinksalcohol, sedatives, and tranquilizers may increase drowsinessbe careful when driving motor vehicle or operating machineryexcitability may occur, especially in children. do not exceed recommended dosage. may cause marked drowsiness. avoid alcoholic drinks. alcohol, sedatives, and tranquilizers may increase drowsiness. be careful when driving motor vehicle or operating machinery. excitability may occur, especially in children.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


Carton 20 count. Alka-Seltzer Plus(R)SEVERE ColdLEMONPOWERFAST FIZZ(TM) SEE NEW DOSING DIRECTIONSNIGHTAspirin (NSAID)/Pain Reliever-Fever Reducer Dextromethorphan HBr Cough SuppressantDoxylamine Succinate AntihistminePhenylephrine Bitartrate Nasal DecongestantNasal CongestionHeadache Body AcheCoughRunny NoseSore Throat20 EFFERVESCENT TABLETS. Nasal Congestion. Headache Body Ache. Cough. Runny Nose. Sore Throat. Carton.

SPL UNCLASSIFIED SECTION.


Drug Facts.

WARNINGS SECTION.


WarningsReyes 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 doctor because these symptoms could be an early sign of Reyes syndrome, rare but serious illness. Allergy alert: Aspirin may cause severe allergic reaction which may include: hivesfacial swellingasthma (wheezing)shockStomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you are age 60 or olderhave had stomach ulcers or bleeding problemstake blood thinning (anticoagulant) or steroid drugtake other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)have or more alcoholic drinks every day while using this producttake more or for longer time than directedSore throat warning: If sore throat is severe, persists for more than days, is accompanied or followed by fever, headache, rash, nausea,or vomiting, consult doctor promptly. Do not use to sedate children.. hives. facial swelling. asthma (wheezing). shock. are age 60 or older. have had stomach ulcers or bleeding problems. take blood thinning (anticoagulant) or steroid drug. take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others). have or more alcoholic drinks every day while using this product. take more or for longer time than directed. Do not useif you are allergic to aspirin or any other pain reliever/fever reducerif you are now taking prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinsons disease), or for weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask doctor or pharmacist before taking this productif you have ever had an allergic reaction to this product or any of its ingredientsin children under 12 years of age. if you are allergic to aspirin or any other pain reliever/fever reducer. if you are now taking prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinsons disease), or for weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask 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. Ask doctor before use ifstomach bleeding warning applies to you you have history of stomach problems, such as heartburnyou have high blood pressure, heart disease, liver cirrhosis, or kidney diseaseyou are taking diureticyou have asthmadiabetesthyroid diseaseglaucomacough that occurs with excessive phlegm (mucus)a breathing problem such as emphysema or chronic bronchitisdifficulty in urination due to enlargement of the prostate glandpersistent or chronic cough such as occurs with smoking, asthma, or emphysemaa sodium-restricted diet stomach bleeding warning applies to you you have history of stomach problems, such as heartburnyou have high blood pressure, heart disease, liver cirrhosis, or kidney diseaseyou are taking diureticyou have asthmadiabetesthyroid diseaseglaucomacough that occurs with excessive phlegm (mucus)a breathing problem such as emphysema or chronic bronchitisdifficulty in urination due to enlargement of the prostate glandpersistent or chronic cough such as occurs with smoking, asthma, or emphysemaa sodium-restricted diet you have history of stomach problems, such as heartburn. you have high blood pressure, heart disease, liver cirrhosis, or kidney disease. you are taking diuretic. you have asthmadiabetesthyroid diseaseglaucomacough that occurs with excessive phlegm (mucus)a breathing problem such as emphysema or chronic bronchitisdifficulty in urination due to enlargement of the prostate glandpersistent or chronic cough such as occurs with smoking, asthma, or emphysemaa sodium-restricted diet asthma. diabetes. thyroid disease. glaucoma. cough that occurs with excessive phlegm (mucus). breathing problem such as emphysema or chronic bronchitis. difficulty in urination due to enlargement of the prostate gland. persistent or chronic cough such as occurs with smoking, asthma, or emphysema. sodium-restricted diet. Ask doctor or pharmacist before use if you aretaking prescription drug for goutdiabetesarthritis taking sedatives or tranquilizers taking prescription drug for goutdiabetesarthritis gout. diabetes. arthritis taking sedatives or tranquilizers When using this productdo not exceed recommended dosagemay cause marked drowsinessavoid alcoholic drinksalcohol, sedatives, and tranquilizers may increase drowsinessbe careful when driving motor vehicle or operating machineryexcitability may occur, especially in children. do not exceed recommended dosage. may cause marked drowsiness. avoid alcoholic drinks. alcohol, sedatives, and tranquilizers may increase drowsiness. be careful when driving motor vehicle or operating machinery. excitability may occur, especially in children. Stop use and ask doctor ifan 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 stoolshave stomach pain that does not get better pain, cough, or nasal congestion gets worse or lasts more than daysfever gets worse or lasts more than daysredness or swelling is presentnew symptoms occurringing in the ears or loss of hearing occurscough comes back or occurs with rash or headache that lasts. These could be signs of serious condition.nervousness, dizziness, or sleeplessness occurs. 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 stoolshave stomach pain that does not get better 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 days. fever gets worse or lasts more than 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 serious condition.. nervousness, dizziness, or sleeplessness occurs. If pregnant or breast-feeding, ask health professional before use. It is especially important not to use aspirin during the last months of pregnancy unless definitely directed to do so by doctor because it may cause problems in the unborn child or complications during delivery.. Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center right away.