Panadol description, usages, side effects, indications, overdosage, supplying and lots more!

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Panadol

GlaxoSmithKline Consumer Healthcare LP

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Acetaminophen 500 mg

Phenylephrine HCl 5 mg

Pain reliever/fever reducer

Nasal decongestant

  • •temporarily relieves these symptoms due to the common cold or flu:
    • ∘nasal congestion
    • ∘stuffy nose
    • ∘sore throat
    • ∘headache
    • ∘sinus congestion and pressure
    • ∘minor aches and pains
  • •temporarily reduces fever

Liver Warning: this product contains acetaminophen. Severe liver damage may occur if you take

  • •more than 8 caplets in 24 hours, which is the maximum daily amount
  • •with other drugs containing acetaminophen
  • •3 or more alcoholic drinks every day while using this product

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

  • •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.

Ask a doctor before use if you have

  • •liver disease
  • •heart disease
  • •thyroid disease
  • •diabetes
  • •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

  • •you get nervous, dizzy or sleepless
  • •pain or nasal congestion gets worse or lasts more than 7 days
  • •fever gets worse or lasts more than 3 days
  • •redness or swelling is present
  • •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.

  • do not take more than directed (see overdose warning)
  • •adults and children 12 years of age and over: take 2 caplets every 6 hours as needed
  • •do not take more than 8 caplets in 24 hours
  • •children under 12 years of age: ask a doctor
  • •store below 30°C (86°F)

hypromellose, microcrystalline cellulose, polyethylene glycol, potassium sorbate, povidone, pregelatinized starch, sodium lauryl sulfate, starch, stearic acid, talc

1-800-981-3511 (English/Spanish) weekdays

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

Distributed by:

GlaxoSmithKline

Consumer Healthcare, L.P.

Moon Township, PA 15108

Made in Ireland

Principal Display Panel

NDC 0135-0459-02

PANADOL ®

MAXIMUM STRENGTH

COLD + FLU

NON-DROWSY

ACETAMINOPHEN

Pain Reliever/Fever Reducer

PHENYLEPHRINE HCl

Nasal Decongestant

24 Caplets

©2011 GlaxoSmithKline

30108XC

Panadol

acetaminophen and phenylephrine HCl TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0135-0459
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 500 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
HYPROMELLOSES
cellulose, microcrystalline
polyethylene glycol 400
POTASSIUM SORBATE
POVIDONES
STARCH, CORN
SODIUM LAURYL SULFATE
STEARIC ACID
talc

Product Characteristics

Color Size Imprint Code Shape
WHITE 18 mm MS OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 8 in 1 BLISTER PACK
2 NDC:0135-0459-01 2 in 1 POUCH
3 NDC:0135-0459-03 50 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2011-08-31


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Be sure to consult your doctor before taking any medication!
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