DOSAGE & ADMINISTRATION SECTION.
Directions. Directions. do not take more than the recommended dose. adults and children 12 years and over: take tablets every hours. Do not exceed 12 tablets in 24 hours or as directed by doctor.. do not swallow tablets whole. Chew or crush tablets completely before swallowing.. children under 12 years: do not use.
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INACTIVE INGREDIENT SECTION.
Inactive ingredients anhydrous citric acid, betadex, carboxymethylcellulose, colloidal silicon dioxide, ethylcellulose, flavors,magnesium stearate, mannitol, microcrystalline cellulose, polyethylene,sodium bicarbonate, sodium starch glycolate, stearicacid, sucralose, xylitol.
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INDICATIONS & USAGE SECTION.
Uses temporarily relieves these symptoms due to cold or flu:. minor aches and pains headache cough. runny nose sneezing sore throat. temporarily reduces fever.
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OTHER SAFETY INFORMATION.
Other information each tablet contains: sodium 17 mg ststore between 20 oC to 25 oC (68 oF to 77 oF). Avoid excessive heat above 40 oC (104 oF).
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OTC - ACTIVE INGREDIENT SECTION.
Active ingredients (in each tablet) PurposesAcetaminophen 162.5 mg.........................Pain reliever/fever reducerChlorpheniramine maleate mg..................................AntihistamineDextromethorphan hydrobromide mg................Cough suppressant.
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OTC - ASK DOCTOR SECTION.
Ask doctor before use if you have liver disease glaucoma cough that is accompanied by excessive phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma,or emphysema breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland 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 ornonprescription). If you are not sure whether drug containsacetaminophen, ask doctor or pharmacist. 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 drugcontains an MAOI, ask doctor or pharmacist before taking thisproduct. 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 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 - QUESTIONS SECTION.
Questions or comments. Questions or comments 1-800-986-0369 (Mon-Fri 8AM 8PM EST).
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OTC - STOP USE SECTION.
Stop use and ask doctor if. pain or cough 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. Thesecould be signs of serious condition.
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OTC - WHEN USING SECTION.
When using this product may cause marked drowsiness alcohol, sedatives, and tranquilizers may increase the drowsiness effect avoid alcoholic drinks be careful when driving motor vehicle or operating machinery excitability may occur, especially in children.
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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 12 tablets in 24 hours, which is the maximum daily amount for this product. 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. Do not use with any other drug containing acetaminophen (prescription ornonprescription). If you are not sure whether drug containsacetaminophen, ask doctor or pharmacist. 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 drugcontains an MAOI, ask doctor or pharmacist before taking thisproduct. if you have ever had an allergic reaction to this product or any of itsingredients in children under 12 years of age. Ask doctor before use if you have liver disease glaucoma cough that is accompanied by excessive phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma,or emphysema breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland sodium-restricted diet. Ask doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers. When using this product may cause marked drowsiness alcohol, sedatives, and tranquilizers may increase the drowsiness effect avoid alcoholic drinks be careful when driving motor vehicle or operating machinery excitability may occur, especially in children. Stop use and ask doctor if. pain or cough 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. Thesecould be signs of serious condition.. If pregnant or breast-feeding, ask health professional before use. 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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