Drug Facts Active Ingredients (In Each Caplet)

EXCEDRIN EXTRA STRENGTH- acetaminophen, as pirin, caffeine tablet, film coated
Navajo Manufacturing Company Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they
comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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Excedrin® Extra Strength
Drug Facts
Active ingredients (in each caplet)

Acetaminophen 250 mg
Aspirin 250 mg (NSAID*)
Caffeine 65 mg
Purpos es
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 s yndrome: 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 us e
• 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
As k a doctor before us e 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
As k a doctor or pharmacis t before us e 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 us e and as k 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 breas t-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:
EXCEDRIN EXTRA STRENGTH
acetaminophen, aspirin, caffeine tablet, film coated
Product Information
Prod uct T yp e HUMAN O TC DRUG Ite m Cod e (S ource ) NDC:6 7751-141(NDC:0 0 6 7-20 0 0 )
Route of Ad minis tration O RAL
Active Ing redient/Active Moiety

Ing redient Name Basis o f Streng th Streng th
ACETAMINO PHEN (UNII: 36 2O 9 ITL9 D) (ACETAMINO PHEN - UNII:36 2O 9 ITL9 D) ACETAMINO PHEN 250 mg
ASPIRIN (UNII: R16 CO 5Y76 E) (ASPIRIN - UNII:R16 CO 5Y76 E) ASPIRIN 250 mg
CAFFEINE (UNII: 3G6 A5W338 E) (CAFFEINE - UNII:3G6 A5W338 E) CAFFEINE 6 5 mg
Inactive Ing redients

Ing redient Name Streng th
BENZO IC ACID (UNII: 8 SKN0 B0 MIM)
CARNAUBA WAX (UNII: R12CBM0 EIZ)
FD&C BLUE NO . 1 (UNII: H3R47K3TBD)
HYDRO XYPRO PYL CELLULO SE, UNSPECIFIED (UNII: 9 XZ8 H6 N6 O H)
HYPRO MELLO SE, UNSPECIFIED (UNII: 3NXW29 V3WO )
LIGHT MINERAL O IL (UNII: N6 K578 7Q VP)
MICRO CRYSTALLINE CELLULO SE (UNII: O P1R32D6 1U)
PO LYSO RBATE 2 0 (UNII: 7T1F30 V5YH)
PO VIDO NE (UNII: FZ9 8 9 GH9 4E)
PRO PYLENE GLYCO L (UNII: 6 DC9 Q 16 7V3)
SO RBITAN MO NO LAURATE (UNII: 6 W9 PS8 B71J)
STEARIC ACID (UNII: 4ELV7Z6 5AP)
TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)
Product Characteristics
Color white S core no sc o re
S hap e CAPSULE S iz e 18 mm
Flavor Imp rint Cod e E
Contains
Packag ing
# Item Co de Packag e Descriptio n Marketing Start Date Marketing End Date
1 NDC:6 7751-141-0 1 1 in 1 CARTO N 0 9 /16 /20 16
1 2 in 1 PO UCH; Type 0 : No t a Co mbina tio n Pro duc t
2 NDC:6 7751-141-0 2 2 in 1 CARTO N 0 9 /16 /20 16
3 NDC:6 7751-141-0 3 12 in 1 BO X 0 1/22/20 18
Marketing Information
Marke ting Cate gory Ap p lication Numb e r or Monograp h Citation Marke ting S tart Date Marke ting End Date
O TC mo no gra ph no t fina l pa rt343 0 9 /16 /20 16
Labeler - Navajo Manufacturing Company Inc. (091917799)
Establishment
Name Ad d re s s ID/FEI Bus ine s s Op e rations
Na va jo Ma nufa c turing Co mpa ny Inc . 136 9 41411 re la be l(6 7751-141)
Revised: 5/2019 Navajo Manufacturing Company Inc.

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Drug Facts Active Ingredients (In Each Caplet)

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EXCEDRIN EXTRA STRENGTH- acetaminophen, as pirin, caffeine tablet, film coated

Navajo Manufacturing Company Inc.

Active ingredients (in each caplet)

As k a doctor or pharmacis t before us e if

Stop us e and as k a doctor if

If pregnant or breas t-feeding,

Keep out of reach of children.

Route of Ad minis tration O RAL

Active Ing redient/Active Moiety

Inactive Ing redients

Labeler - Navajo Manufacturing Company Inc. (091917799)

Revised: 5/2019 Navajo Manufacturing Company Inc.

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