Excedrin

Novartis Consumer Health, Inc.

 Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient
• Purpose
• Excedrin Uses
• Warnings
• Do Not Use
• Ask a doctor before use if you have
• Ask a doctor or pharmacist before use if you are
• When using this product
• Stop use and ask a doctor if
• If pregnant or breast-feeding,
• Keep Out of Reach of Children
• Overdose
• Directions
• Excedrin Other information
• Inactive ingredients
• Questions or comments?
• Additional Information
• Principal Display
• Out of Carton Label (1)
• Out of Carton Label (2)

FULL PRESCRIBING INFORMATION

Active ingredient

Acetaminophen 500 mg

Diphenhydramine citrate 38 mg

Purpose

Pain reliever

Nighttime sleep-aid

Excedrin Uses

for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness.

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

• more than 2 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

Do Not Use

• if you are allergic to acetaminophen
• 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

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
• taking sedatives or tranquilizers

When using this product

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

Stop use and ask a doctor if

• any new symptoms occur
• sleeplessness lasts continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
• pain gets worse or lasts for more than 10 days
• painful area is red or swollen
• fever gets worse or lasts for more than 3 days

If pregnant or breast-feeding,

ask a health professional before use.

Keep Out of Reach of Children

Overdose

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

• do not use more than directed
• do not use in children under 12 years of age
• adults and children 12 years of age and over: take 2 caplets at bedtime, if needed, or as directed by a doctor

Excedrin Other information

• store at controlled room temperature 20°-25°C (68°-77°F)
• read all product information before using. Keep this box for important information.

Inactive ingredients

benzoic acid, carnauba wax, croscarmellose sodium, D&C yellow #10 lake, FD&C blue #1 lake, hypromellose, light mineral oil, magnesium stearate, microcrystalline cellulose, polysorbate 20, povidone, pregelatinized starch, propylene glycol, simethicone emulsion, sodium citrate, sorbitan monolaurate, stearic acid, titanium dioxide

Questions or comments?

1-800-468-7746

Distr. By: Novartis Consumer Health, Inc.

Parsippany, NJ 07054-0622 ©2008

Visit us at www.excedrin.com

Additional Information

Country of origin -- USA per NAFTA requirements

Tamper-Evident Feature –

  Exempt packaging statement -- 

READ ALL PRODUCT INFORMATION BEFORE USING. KEEP BOX FOR IMPORTANT INFORMATION.

Principal Display

Out of Carton Label (1)

Out of Carton Label (2)