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EXCEDRIN

Novartis Consumer Health, Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Acetaminophen 500 mg

Caffeine 65 mg

Purpose

Pain reliever

EXCEDRIN Uses

• temporarily relieves minor aches and pains due to:

• headache • muscular aches

Warnings

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

Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat.

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.

Ask a doctor before use if you have

  • liver disease

Ask a doctor or pharmacists

  • taking the blood thinning drug warfarin

Stop use and ask a doctor if

  • any new symptoms occur
  • painful area is red or swollen
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days

Pregnancy or Breast Feeding

ask a health professional before use.

Keep Out of Reach of Children

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
  • adults and children 12 years and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours

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, D&C red # 27 lake, D&C yellow # 10 lake, FD&C blue # 1 lake, FD&C red # 40, hypromellose, light mineral oil, magnesium stearate, microcrystalline cellulose, polysorbate 20, povidone, pregelatinized starch, propylene glycol, simethicone emulsion, sorbitan monolaurate, stearic acid, titanium dioxide

Questions or comments

1-800-468-7746

Distr. By:  

Novartis Consumer Health, Inc.

Parsippany, NJ 07054-0622

Visit us at www.excedrin.com

Principal Display

EXCEDRIN

EXCEDRIN

Acetaminophine, caffeine TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0067-2045
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 500 mg
CAFFEINE 65 mg

Inactive Ingredients

Ingredient Name Strength
BENZOIC ACID
carnauba wax
cellulose, microcrystalline
D&C RED NO. 27
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C RED NO. 40
hypromellose
LIGHT MINERAL OIL
MAGNESIUM STEARATE
POLYSORBATE 20
povidone
propylene glycol
STARCH, CORN
SORBITAN MONOLAURATE
STEARIC ACID
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
RED (Red) 18 mm ETH CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 24 in 1 BOTTLE
2 NDC:0067-2045-02 2 in 1 POUCH
3 NDC:0067-2045-07 250 in 1 BOTTLE
4 50 in 1 BOTTLE
5 250 in 1 BOTTLE
6 100 in 1 BOTTLE
7 NDC:0067-2045-94 100 in 1 BOTTLE
8 125 in 1 BOTTLE
9 NDC:0067-2045-84 125 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2005-10-31


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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