EXCEDRIN EXTRA STRENGTH- acetaminophen, aspirin, caffeine tablet, film coated

Excedrin Extra Strength by

Drug Labeling and Warnings

Excedrin Extra Strength by is a Otc medication manufactured, distributed, or labeled by Navajo Manufacturing Company Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each caplet)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID*)

Caffeine 65 mg

Purposes

Pain reliever

Pain reliever aid
*nonsteroidal anti-inflammatory drug

Uses

temporarily relieves minor aches and pains due to:
headache a cold arthritis muscular aches  toothache premenstrual & menstrual cramps

Warnings

Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness. Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:  skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away.
Allergy alert: Aspirin may cause a severe allergic reaction which may include:  hives facial swelling asthma (wheezing) shock
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

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
are age 60 or older
have had stomach ulcers or bleeding problems
take a blood thinning (anticoagulant) or steroid drug
take other drugs containing prescription or nonprescription NSAIDs
(aspirin, ibuprofen, naproxen, or others)
have 3 or more alcoholic drinks every day while using this product
take more or for a longer time than directed
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 have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer
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
stomach bleeding warning applies to you
you have a history of stomach problems, such as heartburn
you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
you are taking a diuretic you have asthma

Ask a doctor or pharmacist before use if

you are taking
a prescription drug for diabetes, gout, or arthritis
any other drug, or are under a doctor’s care for any serious condition

Stop use and ask a doctor if

an allergic reaction occurs. Seek medical help right away.  you experience any of the following signs of stomach bleeding:  feel faint vomit blood have bloody or black stools  have stomach pain that does not get better  ringing in the ears or loss of hearing occurs 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 any new symptoms occur These could be signs of a serious condition

If pregnant or breast-feeding,

ask a health care professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

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  drink a full glass of water with each dose  adults and children 12 years of age and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours  under 12 years: ask a doctor

Other information

store at 20°-25°C (68°-77°F)
read all product information before using. Keep this carton for important information.

Inactive ingredients

benzoic acid, carnauba wax, FD&C blue #1, hydroxypropylcellulose, hypromellose, light mineral oil, microcrystalline cellulose, polysorbate 20, povidone, propylene glycol, simethicone emulsion, sorbitan monolaurate, stearic acid, titanium dioxide

Questions or comments?

1-800-452-0051

Package Labeling:

INGREDIENTS AND APPEARANCE

EXCEDRIN EXTRA STRENGTH 
acetaminophen, aspirin, caffeine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67751-141(NDC:0067-2000)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	250 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	250 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	65 mg

Inactive Ingredients
Ingredient Name	Strength
BENZOIC ACID (UNII: 8SKN0B0MIM)
CARNAUBA WAX (UNII: R12CBM0EIZ)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code	E
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67751-141-01	1 in 1 CARTON	09/16/2016
1		2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 67751-141-02	2 in 1 CARTON	09/16/2016
2		4 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 67751-141-03	12 in 1 BOX	01/22/2018
3		1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	09/16/2016

Labeler - Navajo Manufacturing Company Inc. (091917799)

Establishment
Name	Address	ID/FEI	Business Operations
Navajo Manufacturing Company Inc.		136941411	relabel(67751-141)