EXCEDRIN EXTRA STRENGTH (acetaminophen, aspirin- nsaid, and 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 Select Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each caplet)	Purposes
* nonsteroidal anti-inflammatory drug
Acetaminophen 250 mg	Pain reliever
Aspirin 250 mg (NSAID*)	Pain reliever
Caffeine 65 mg	Pain reliever aid

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 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 card for important information.

Inactive ingredients

benzoic acid, carnauba wax, FD&C blue #1, hydroxypropylcelluose, 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

SPL UNCLASSIFIED SECTION

Repackaged and Distributed by:
Select Corporation
Carrollton, TX 75007

Packaged and distributed by Select Corporation with the permission of
GSK Consumer Healthcare, Warren, NJ 07059

PRINCIPAL DISPLAY PANEL - 2 Caplet Pouch Packet

EXCEDRIN®

EXTRA
STRENGTH

Acetaminophen, Aspirin (NSAID) and Caffeine

Pain Reliever/Pain Reliever Aid

1 Packet of 2 Caplets

INGREDIENTS AND APPEARANCE

EXCEDRIN EXTRA STRENGTH 
acetaminophen, aspirin (nsaid), and caffeine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52904-868(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, unspecified (UNII: FZ989GH94E)
propylene glycol (UNII: 6DC9Q167V3)
dimethicone (UNII: 92RU3N3Y1O)
sorbitan monolaurate (UNII: 6W9PS8B71J)
stearic acid (UNII: 4ELV7Z65AP)
titanium dioxide (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE (White)	Score	no score
Shape	CAPSULE (Capsule-Shaped Tablet)	Size	18mm
Flavor		Imprint Code	E
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52904-868-04	1 in 1 BLISTER PACK	01/23/2016
1		2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 52904-868-05	2 in 1 BLISTER PACK	01/23/2016
2		2 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 52904-868-25	25 in 1 CARTON	01/23/2016
3		2 in 1 POUCH; Type 0: Not a Combination Product
4	NDC: 52904-868-50	50 in 1 CARTON	01/23/2016
4		2 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	01/23/2016

Labeler - Select Corporation (053805599)