PANADOL COLD AND FLU NONDROWSY- acetaminophen and phenylephrine hcl tablet, film coated
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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Active ingredients (in each caplet)
Acetaminophen 500 mg
Phenylephrine HCl 5 mg
Purposes
Pain reliever/fever reducer
Nasal decongestant
Uses
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- temporarily relieves these symptoms due to the common cold or flu:
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- nasal congestion
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- stuffy nose
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- sore throat
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- headache
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- sinus congestion and pressure
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- minor aches and pains
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- temporarily reduces fever
Warnings
Liver Warning: this product contains acetaminophen. Severe liver damage may occur if you take
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- more than 8 caplets in 24 hours, which is the maximum daily amount
- •
- with other drugs containing acetaminophen
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- 3 or more alcoholic drinks every day while using this product
Allergy alert: acetaminophen may cause severe skin reactions.
Symptoms may include:
- •
- skin reddening
- •
- blisters
- •
- rash
If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, ask a doctor promptly.
Do not use
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- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- •
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
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- if you are allergic to acetaminophen or any of the inactive ingredients in this product
Ask a doctor before use if you have
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- liver disease
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- heart disease
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- thyroid disease
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- diabetes
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- high blood pressure
- •
- trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are
taking the blood thinning drug warfarin
When using this product do not exceed recommended dosage
Stop use and ask a doctor if
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- you get nervous, dizzy or sleepless
- •
- pain or nasal congestion gets worse or lasts more than 7 days
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- fever gets worse or lasts more than 3 days
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- redness or swelling is present
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- any new symptoms appear
If pregnant or breast-feeding,
ask a 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 a 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.
Directions
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-
do not take more than directed (see overdose warning)
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- adults and children 12 years of age and over: take 2 caplets every 6 hours, while symptoms persist or as directed by a doctor
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- do not take more than 8 caplets in 24 hours, unless directed by a doctor
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- children under 12 years of age: ask a doctor
Other information
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- store below 30°C (86°F)
Inactive ingredients
hypromellose, microcrystalline cellulose, polyethylene glycol, potassium sorbate, povidone, pregelatinized starch, sodium lauryl sulfate, starch, stearic acid, talc
Questions or comments?
1-800-981-3511 (English/Spanish) weekdays
Principal Display Panel
NDC 0135-0459-02
PANADOL®
MAXIMUM STRENGTH
COLD + FLU
NON-DROWSY
ACETAMINOPHEN
Pain Reliever/Fever Reducer
PHENYLEPHRINE HCl
Nasal Decongestant
SEE NEW WARNINGS INFORMATION
24 CAPLTES
TAMPER EVIDENT FEATURE: This product is protected in a sealed blister. Do not use if blister or printed foil is broken.
READ AND KEEP CARTON FOR COMPLETE INFORMATION
PANADOL and the Beacon design are registered trademarks of the GSK group of companies.
GlaxoSmithKline Consumer Healthcare, L.P.
Moon Township, PA 15108
©2015 GSK group of companies.
All Rights Reserved.
Made in Ireland
30108XD