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

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Excedrin

Novartis Consumer Health, Inc.

 Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




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

TAMPER-EVIDENT BOTTLE

DO NOT USE IF INNER FOIL SEAL IMPRINTED WITH

“SEALED for YOUR PROTECTION”

IS BROKEN OR MISSING

  Exempt packaging statement -- 

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

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

Principal Display

Excedrin
Excedrin PM Caplet

Out of Carton Label (1)

Excedrin
Excedrin Out of Carton Label

Out of Carton Label (2)

Excedrin
Excedrin Out of Carton Label

Excedrin

Acetaminophen, Diphenhydramine Citrate TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0067-2055
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 500 mg
DIPHENHYDRAMINE CITRATE DIPHENHYDRAMINE 38 mg

Inactive Ingredients

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

Product Characteristics

Color Size Imprint Code Shape
BLUE (Light blue) 18 mm PM CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 8 in 1 BOTTLE, PLASTIC
2 24 in 1 BOTTLE, PLASTIC
3 50 in 1 BOTTLE, PLASTIC
4 100 in 1 BOTTLE, PLASTIC
5 NDC:0067-2055-94 100 in 1 BOTTLE, PLASTIC
6 125 in 1 BOTTLE, PLASTIC
7 NDC:0067-2055-86 125 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2009-07-01


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