OTC - ACTIVE INGREDIENT SECTION.
Active ingredients (in each tablet)Acetaminophen 250 mgChlorpheniramine maleate mgDextromethorphan hydrobromide 10 mgPhenylephrine hydrochloride mg.
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OTC - QUESTIONS SECTION.
Questions or comments 1-800-986-0369 (Mon-Fri 9AM 5PM EST).
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DOSAGE & ADMINISTRATION SECTION.
Directions. do not take more than the recommended dose. 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 acesulfame potassium, anhydrous citric acid, aspartame, FD&C red 40, flavors, magnesium stearate, maltodextrin, mannitol, saccharin sodium, sodium bicarbonate.
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INDICATIONS & USAGE SECTION.
Uses temporarily relieves these symptoms due to cold or flu: minor aches and pains headache cough sore throat runny nose sneezing nasal and sinus congestion temporarily reduces fever.
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OTHER SAFETY INFORMATION.
Other information each tablet contains: sodium 416 mg Phenylketonurics: Contains Phenylalanine 5.6 mg Per Tablet store at room temperature. Avoid excessive heat.
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OTC - ASK DOCTOR SECTION.
Ask doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes glaucoma cough 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.
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OTC - ASK DOCTOR/PHARMACIST SECTION.
Ask doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers.
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OTC - DO NOT USE SECTION.
Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether drug contains acetaminophen, ask doctor or pharmacist. 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.
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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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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OTC - PREGNANCY OR BREAST FEEDING SECTION.
If pregnant or breast-feeding, ask health professional before use.
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OTC - PURPOSE SECTION.
PurposesPain reliever/fever reducerAntihistamineCough suppressantNasal decongestant.
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OTC - STOP USE SECTION.
Stop use and ask doctor if. 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. 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 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.
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
Alka-SeltzerPLUS(R)SEVERECold& FluCITRUSAcetaminophen Pain Reliever-Fever ReducerChlorpheniramine Maleate AntihistamineDextromethorphan HBr Cough SuppressantPhenylephrine Hydrochloride Nasal DecongestantFever Body AcheCoughNasal CongestionRunny NoseSore Throat20 EFFERVESCENT TABLETS. Fever Body Ache. Cough. Nasal Congestion. Runny Nose. Sore Throat. Carton 20 count.
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SPL UNCLASSIFIED SECTION.
Drug Facts.
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WARNINGS SECTION.
WarningsLiver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours. with other drugs containing acetaminophen. or more alcoholic drinks every day while using this productAllergy alert: Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include: skin reddening blisters rash hives. facial swelling asthma (wheezing) shockIf 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 days, is accompanied or followed by fever, headache, rash, nausea,or vomiting, consult doctor promptly.Do not use to sedate children.
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