OTC - QUESTIONS SECTION.
Questions or comments. 1-800-455-7139.
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ADVERSE REACTIONS SECTION.
Allergy alert:. acetaminophen may cause severe skin reactions. Symptoms may include:skin reddeningblistersrashIf skin reaction occurs, stop use and seek medical help right away.. skin reddening. blisters. rash.
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DOSAGE & ADMINISTRATION SECTION.
Directions. do not take more than directed(see overdose warning) adults and children 12 years of age and over: take caplets at bedtime, if needed, or as directed by doctordo not give to children under 12 years of age. do not take more than directed(see overdose warning) adults and children 12 years of age and over: take caplets at bedtime, if needed, or as directed by doctor. do not give to children under 12 years of age.
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INACTIVE INGREDIENT SECTION.
Inactive ingredients. carnauba wax, crospovidone, FD&C blue aluminum lake, FD&C blue aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide.
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INDICATIONS & USAGE SECTION.
Uses. temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness. temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness.
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OVERDOSAGE SECTION.
Overdose warning:. Taking more than the recommended dose can cause serious health problems. 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 - ACTIVE INGREDIENT SECTION.
Active ingredients (in each caplet). Acetaminophen 500 mgDiphenhydramine HCl 25 mg.
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OTC - ASK DOCTOR SECTION.
Ask doctor before use if you have. liver diseaseglaucomaa breathing problem such as emphysema or chronic bronchitistrouble urinating due to an enlarged prostate gland. liver disease. glaucoma. breathing problem such as emphysema or chronic bronchitis. trouble urinating due to an enlarged prostate gland.
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OTC - ASK DOCTOR/PHARMACIST SECTION.
Ask doctor or pharmacist before use if you are taking. the blood thinning drug warfarinsedatives or tranquilizers. the blood thinning drug warfarin. 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.with any other product containing diphenhydramine, even one used on skinin children under 12 years of ageif you are allergic to acetaminophen or any of the inactive ingredients in this product. with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether drug contains acetaminophen, ask doctor or pharmacist.. with any other product containing diphenhydramine, even one used on skin. in children under 12 years of age. if you are allergic to acetaminophen or any of the inactive ingredients in this product.
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OTC - KEEP OUT OF REACH OF CHILDREN SECTION.
Keep out of reach of children.
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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.
Purposes. Pain relieverNighttime sleep-aid.
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OTC - STOP USE SECTION.
Stop use and ask doctor if. sleeplessness persists continuously for more than weeks. Insomnia may be symptom of serious underlying medical illness.pain gets worse or lasts more than 10 daysredness or swelling is presentany new symptoms appearThese could be signs of serious condition.. sleeplessness persists continuously for more than weeks. Insomnia may be symptom of serious underlying medical illness.. pain gets worse or lasts more than 10 days. redness or swelling is present. any new symptoms appear.
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OTC - WHEN USING SECTION.
When using this product. drowsiness will occuravoid alcoholic drinksbe careful when driving motor vehicle or operating machinery. drowsiness will occur. avoid alcoholic drinks. be careful when driving motor vehicle or operating machinery.
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
Principal Display Panel. NDC 0135-0608-01PANADOLEXTRA STRENGTHPMACETAMNOPHENPain RelieverDIPHENHYDRAMINE HClNighttime Sleep-Aid24 CAPLETSTamper-Evident Feature:Do not use if printed bottle seal (under cap) is missing or broken. READ AND KEEP CARTON FOR COMPLETE INFORMATIONTrademarks are owned by or licensed to the GSK group of companies.Distributed by:GSKConsumer Healthcare, Warren, NJ 07059 (C)2016 GSK group of companies or its licensor.101639XE. 101639XEPanadol PM24 ct.JPG.
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STORAGE AND HANDLING SECTION.
Other information. store below 25C (77F). store below 25C (77F).
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WARNINGS SECTION.
Warnings. Liver warning:This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hourswith other drugs containing acetaminophen3 or more alcoholic drinks every day while using this product. more than 4,000 mg of acetaminophen in 24 hours. with other drugs containing acetaminophen. or more alcoholic drinks every day while using this product. Allergy alert:. acetaminophen may cause severe skin reactions. Symptoms may include:skin reddeningblistersrashIf skin reaction occurs, stop use and seek medical help right away.. skin reddening. blisters. rash. 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.with any other product containing diphenhydramine, even one used on skinin children under 12 years of ageif you are allergic to acetaminophen or any of the inactive ingredients in this product. with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether drug contains acetaminophen, ask doctor or pharmacist.. with any other product containing diphenhydramine, even one used on skin. in children under 12 years of age. if you are allergic to acetaminophen or any of the inactive ingredients in this product. Ask doctor before use if you have. liver diseaseglaucomaa breathing problem such as emphysema or chronic bronchitistrouble urinating due to an enlarged prostate gland. liver disease. glaucoma. breathing problem such as emphysema or chronic bronchitis. trouble urinating due to an enlarged prostate gland. Ask doctor or pharmacist before use if you are taking. the blood thinning drug warfarinsedatives or tranquilizers. the blood thinning drug warfarin. sedatives or tranquilizers. When using this product. drowsiness will occuravoid alcoholic drinksbe careful when driving motor vehicle or operating machinery. drowsiness will occur. avoid alcoholic drinks. be careful when driving motor vehicle or operating machinery. Stop use and ask doctor if. sleeplessness persists continuously for more than weeks. Insomnia may be symptom of serious underlying medical illness.pain gets worse or lasts more than 10 daysredness or swelling is presentany new symptoms appearThese could be signs of serious condition.. sleeplessness persists continuously for more than weeks. Insomnia may be symptom of serious underlying medical illness.. pain gets worse or lasts more than 10 days. redness or swelling is present. any new symptoms appear. If pregnant or breast-feeding,. ask health professional before use.. Keep out of reach of children.. Overdose warning:. Taking more than the recommended dose can cause serious health problems. 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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