PANADOL

GlaxoSmithKline Consumer Healthcare LP

Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Principal Display Panel

FULL PRESCRIBING INFORMATION

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Pain reliever

Nighttime sleep-aid

• •temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Liver 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
• •3 or more alcoholic drinks every day while using this product

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.
• •with any other product containing diphenhydramine, even one used on skin
• •in children under 12 years of age
• •with other antihistamines

Ask a doctor before use if you have

• •liver disease
• •glaucoma
• •a breathing problem such as emphysema or chronic bronchitis
• •trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are taking

• •the blood thinning drug warfarin
• •sedatives or tranquilizers

When using this product

• •drowsiness will occur
• •avoid alcoholic drinks
• •be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

• •sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
• •pain gets worse or lasts more than 10 days
• •redness or swelling is present
• •any new symptoms appear

These could be signs of a serious condition.

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 at bedtime, if needed, or as directed by a doctor
• •do not give to children under 12 years of age

• •store below 30°C (86°F)

FD&C blue #1, FD&C blue #2, hypromellose, polyethylene glycol, polysorbate 80, potassium sorbate, povidone, pregelatinized starch, starch, stearic acid, talc, titanium dioxide. Printed with edible ink.

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

Tamper Evident Feature: Do not use if printed bottle seal (under cap) is missing or broken.

Distributed by:

GlaxoSmithKline

Consumer Healthcare, L.P.

Moon Township, PA 15108 U.S.A.

Read and keep carton for complete information

Principal Display Panel

NDC 0135-0150-02

PANADOL

EXTRA STRENGTH

PM

ACETAMINOPHEN

Pain Reliever

DIPHENHYDRAMINE HCl

Nighttime Sleep-Aid

50 Caplets

©2011 GlaxoSmithKline

101689XA