DOSAGE & ADMINISTRATION SECTION.
Directions. 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: do not use.
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INACTIVE INGREDIENT SECTION.
Inactive ingredients. Inactive ingredients anhydrous citric acid, calcium silicate, dimethicone, FD&C red 40, FD&C yellow 6, flavor, mannitol, potassium bicarbonate, povidone, sodium bicarbonate, sucralose.
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INDICATIONS & USAGE SECTION.
Uses. Uses temporarily relieves these symptoms due to cold with cough: minor aches and pains headache cough nasal and sinus congestion sore throat temporarily reduces fever.
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OTHER SAFETY INFORMATION.
Other information. Other information each tablet contains: potassium 80 mg; sodium 356 mg store at room temperature. Avoid excessive heat.
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OTC - ACTIVE INGREDIENT SECTION.
Active ingredients. Active ingredients (in each tablet) PurposesAspirin 325 mg (NSAID)..........................Pain reliever/fever reducerDextromethorphan hydrobromide 10 mg...............Cough suppressantPhenylephrine bitartrate 7.8 mg............................Nasal decongestantnonsteroidal anti-inflammatory drug.
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OTC - ASK DOCTOR SECTION.
Ask doctor. Ask doctor before use if stomach bleeding warning applies to you 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 asthma thyroid disease diabetes cough with excessive phlegm (mucus) 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.
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OTC - ASK DOCTOR/PHARMACIST SECTION.
Ask doctor or pharmacist. Ask doctor or pharmacist before use if you are. taking prescription drug for gout diabetes arthritis.
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OTC - DO NOT USE SECTION.
Do not use. Do not use 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 emotionalconditions, or Parkinsons disease), or for weeks after stoppingthe MAOI drug. If you do not know if your prescription drug containsan MAOI, ask doctor or pharmacist before taking this product. if you have ever had an allergic reaction to this product or any of itsingredients in children under 12 years of age.
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OTC - KEEP OUT OF REACH OF CHILDREN SECTION.
Keep out of reach. Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center right away.
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OTC - PREGNANCY OR BREAST FEEDING SECTION.
Pregnant or breast feeding. 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.
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OTC - QUESTIONS SECTION.
Questions. Questions or comments 1-800-986-0369 (Mon-Fri 9AM 5PM EST).
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OTC - STOP USE SECTION.
Stop use. Stop use and ask 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 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.
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OTC - WHEN USING SECTION.
When using this product. When using this product do not exceed recommended dosage.
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
Carton 20 count. Alka-Seltzer Plus(R)SEVEREColdCITRUSPOWERFAST(TM) FIZZNEW IMPROVED FLAVORNON-DROWSYASPIRIN (NSAID) Pain Reliever-Fever ReducerDextromehorphan HBr Cough SuppressantPhenylephrine Bitartrate Nasal DecongestantFever Body AcheNasal CongestionSinus PressureSore ThroatCough20 EFFERVESCENT TABLETS. Fever Body Ache. Nasal Congestion. Sinus Pressure. Sore Throat. Cough. ASP Cold 1. ASP Cold 2.
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SPL UNCLASSIFIED SECTION.
Drug Facts.
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WARNINGS SECTION.
Warnings. 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: hives facial swelling asthma (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 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 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. Do not use 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 emotionalconditions, or Parkinsons disease), or for weeks after stoppingthe MAOI drug. If you do not know if your prescription drug containsan MAOI, ask doctor or pharmacist before taking this product. if you have ever had an allergic reaction to this product or any of itsingredients in children under 12 years of age. Ask doctor. Ask doctor before use if stomach bleeding warning applies to you 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 asthma thyroid disease diabetes cough with excessive phlegm (mucus) 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. Ask doctor or pharmacist before use if you are. taking prescription drug for gout diabetes arthritis. When using this product. When using this product do not exceed recommended dosage. Stop use. Stop use and ask 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 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. Pregnant or breast feeding. 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. Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center right away.
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