Excedrin Extra Strength: Package Insert and Label Information

EXCEDRIN EXTRA STRENGTH- acetaminophen, aspirin and 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.

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, hypromellose, light mineral oil, low-substituted hydroxypropyl cellulose, microcrystalline cellulose, polysorbate 20, povidone, propylene glycol, simethicone, sorbitan monolaurate, stearic acid, titanium dioxide

Questions or comments?

1-800-468-7746

Package Labeling:

Packaged and Distributed by
Navajo Mfg. Co. Inc. with permission
of GSK Consumer Healthcare
GSK Consumer Healthcare , Warren, NJ 07059
©2021 GSK group of companies or its licensor.
All rights reserved.
(800) 468-7746 Visit us at www.excedrin.com

The Excedrin trademark is owned by or licensed to the group of GSK companies The Handy Solutions trademark is owned by Navajo Manufacturing Company Inc.

Extra Strength Excedrin
(click image for full-size original)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 250 mg
ASPIRIN (ASPIRIN) ASPIRIN 250 mg
CAFFEINE (CAFFEINE) CAFFEINE 65 mg
Inactive Ingredients
Ingredient Name Strength
BENZOIC ACID
CARNAUBA WAX
FD&C BLUE NO. 1
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
LIGHT MINERAL OIL
MICROCRYSTALLINE CELLULOSE
POLYSORBATE 20
POVIDONE
PROPYLENE GLYCOL
SORBITAN MONOLAURATE
STEARIC ACID
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code E
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67751-141-01 1 POUCH in 1 CARTON contains a POUCH
1 2 TABLET, FILM COATED in 1 POUCH This package is contained within the CARTON (67751-141-01)
2 NDC:67751-141-02 2 POUCH in 1 CARTON contains a POUCH
2 4 TABLET, FILM COATED in 1 POUCH This package is contained within the CARTON (67751-141-02)
3 NDC:67751-141-03 12 POUCH in 1 BOX contains a POUCH
3 1 TABLET, FILM COATED in 1 POUCH This package is contained within the BOX (67751-141-03)
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 Operations
Navajo Manufacturing Company Inc. 136941411 relabel (67751-141)

Revised: 08/2022 Navajo Manufacturing Company Inc.

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