Label: EXCEDRIN EXTRA STRENGTH HEADACHE (acetaminophen, aspirin- nsaid, caffeine tablet, film coated
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NDC Code(s):
0067-2002-01,
0067-2002-02,
0067-2002-03,
0067-2002-04, view more0067-2002-05, 0067-2002-06, 0067-2002-07, 0067-2002-08, 0067-2003-01, 0067-2003-02
- Packager: Haleon US Holdings LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 28, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each caplet)
- Purposes
- Uses
-
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.
- Directions
- Other information
- Inactive ingredients (24 ct)
- Inactive ingredients (100 ct)
- Questions or comments?
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Package/Label Principal Display Panel (24 ct.)
EXCEDRIN
EXTRA STRENTH HEADACHE
Acetaminophen 250 mg,Aspirin 250 mg (NSAID)
and Caffeine 65 mg
Pain Reliever / Pain Reliever AidACTUAL SIZE
24 CAPLETS
TAMPER-EVIDENT BOTTLE
DO NOT USE IF INNER SAFETY SEAL IMPRINTED WITH
“SEALED for YOUR PROTECTION” IS BROKEN OR MISSING
Distributed by: Haleon, Warren, NJ 07059
©2023 Haleon or licensor. Trademarks are owned by or licensed
to the Haleon group of companies. 62000000201911 -
Package/Label Principal Display Panel (100 ct.)
EXCEDRIN
EXTRA STRENGTH HEADACHE
Acetaminophen 250 mg,Aspirin 250 mg (NSAID)
and Caffeine 65 mg
Pain Reliever / Pain Reliever AidACTUAL SIZE
100
CAPLETSTAMPER-EVIDENT BOTTLE
DO NOT IF USE PRINTED INNER SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
Distributed by: Haleon, Warren, NJ 07059
©2023 Haleon or licensor. Trademarks are owned by or licensed
to the Haleon group of companies. -
INGREDIENTS AND APPEARANCE
EXCEDRIN EXTRA STRENGTH HEADACHE
acetaminophen, aspirin (nsaid), caffeine tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0067-2002 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) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) LIGHT MINERAL OIL (UNII: N6K5787QVP) LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 2165RE0K14) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYSORBATE 20 (UNII: 7T1F30V5YH) POVIDONE, UNSPECIFIED (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:0067-2002-01 1 in 1 CARTON 01/01/2024 1 24 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:0067-2002-02 1 in 1 CARTON 01/01/2024 2 30 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:0067-2002-03 1 in 1 CARTON 01/01/2024 3 50 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:0067-2002-04 1 in 1 CARTON 01/01/2024 4 100 in 1 BOTTLE; Type 0: Not a Combination Product 5 NDC:0067-2002-05 1 in 1 CARTON 01/01/2024 5 125 in 1 BOTTLE; Type 0: Not a Combination Product 6 NDC:0067-2002-06 1 in 1 CARTON 01/01/2024 6 200 in 1 BOTTLE; Type 0: Not a Combination Product 7 NDC:0067-2002-07 1 in 1 CARTON 01/01/2024 7 250 in 1 BOTTLE; Type 0: Not a Combination Product 8 NDC:0067-2002-08 300 in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 01/01/2024 EXCEDRIN EXTRA STRENGTH HEADACHE
acetaminophen, aspirin (nsaid), caffeine tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0067-2003 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 STARCH, CORN (UNII: O8232NY3SJ) CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white Score no score Shape CAPSULE Size 18mm Flavor Imprint Code ES Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0067-2003-01 1 in 1 CARTON 01/01/2024 1 100 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:0067-2003-02 1 in 1 CARTON 01/01/2024 2 200 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 01/01/2024 Labeler - Haleon US Holdings LLC (079944263)
