Excedrin (acetaminophen 500 mg diphenhydramine citrate 38 mg) Dailymed

Active Ingredient

Acetaminophen 500 mg

Diphenhydramine citrate 38 mg

Purpose

Pain reliever

Nighttime sleep-aid

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

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 –

Boxed Warning section

TAMPER-EVIDENT BOTTLE

DO NOT USE IF INNER FOIL SEAL IMPRINTED WITH

“SEALED for YOUR PROTECTION”

IS BROKEN OR MISSING

  Exempt packaging statement -- 

Boxed Warning section

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

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