Label: EXCEDRIN MIGRAINE RELIEF (acetaminophen, aspirin- nsaid, caffeine tablet, film coated
-
NDC Code(s):
0067-2042-01,
0067-2042-02,
0067-2042-03,
0067-2042-04, view more0067-2042-05, 0067-2042-06, 0067-2042-07, 0067-2042-08
- Packager: Haleon US Holdings LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 5, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each caplet)
- Purposes
- Use
-
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 2 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
Medication overuse headache warning:Headaches may worsen if this product is used for 10 or more days per month.
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 doctor before use if
• you have never had migraines diagnosed by a health professional • you have a headache that is different from your usual migraines • you have the worst headache of your life • you have fever and stiff neck • you have headaches beginning after or caused by head injury, exertion, coughing or bending • you experienced your first headache after the age of 50 • you have daily headaches • you have a migraine so severe as to require bed rest • 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 • you have problems or serious side effects from taking pain relievers or fever reducers • you have vomiting with your migraine headache
Ask a doctor or pharmacist before use if you are
• taking a prescription drug for: • diabetes • gout • arthritis • under a doctor’s care for any serious condition • taking any other drug • taking any other product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer
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 • your migraine is not relieved or worsens after first dose • new or unexpected symptoms occur • ringing in the ears or loss of hearing occurs
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
EXCEDRIN
MIGRAINE RELIEF
Acetaminophen 250 mg,Aspirin 250 mg (NSAID)
and Caffeine 65 mg
Pain Reliever / Pain Reliever AidACTUAL SIZE
24
CAPLETS*
* CAPSULE-SHAPED TABLETSDistributed by: Haleon, Warren, NJ 07059
©2023 Haleon or licensor. Trademarks are owned by or licensed to the Haleon group of companies. 62000000202358
TAMPER-EVIDENT BOTTLE
DO NOT USE IF INNER FOIL SEAL IMPRINTED WITH
“SEALED for YOUR PROTECTION” IS BROKEN OR MISSING -
INGREDIENTS AND APPEARANCE
EXCEDRIN MIGRAINE RELIEF
acetaminophen, aspirin (nsaid), caffeine tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0067-2042 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 (Capsule-shaped tablet) Size 16mm Flavor Imprint Code E Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0067-2042-01 1 in 1 CARTON 01/01/2024 1 24 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:0067-2042-02 1 in 1 CARTON 01/01/2024 2 30 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:0067-2042-03 1 in 1 CARTON 01/01/2024 3 50 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:0067-2042-04 1 in 1 CARTON 01/01/2024 4 100 in 1 BOTTLE; Type 0: Not a Combination Product 5 NDC:0067-2042-05 1 in 1 CARTON 01/01/2024 5 125 in 1 BOTTLE; Type 0: Not a Combination Product 6 NDC:0067-2042-06 1 in 1 CARTON 01/01/2024 6 200 in 1 BOTTLE; Type 0: Not a Combination Product 7 NDC:0067-2042-07 1 in 1 CARTON 01/01/2024 7 250 in 1 BOTTLE; Type 0: Not a Combination Product 8 NDC:0067-2042-08 300 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 Labeler - Haleon US Holdings LLC (079944263)