Indications and uses
• temporarily relieves minor aches and pains due to: o headache o a cold o arthritis o muscular aches o toothache o premenstrual & menstrual cramps
• temporarily relieves minor aches and pains due to: o headache o a cold o arthritis o muscular aches o toothache o premenstrual & menstrual cramps
• do not use more than directed • drink a full glass of water with each dose • adults and children 12 years and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours • children under 12 years: ask a doctor
Acetaminophen 250 mg
Aspirin 250 mg (NSAID*)
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
Pain reliever
Pain reliever
Pain reliever aid
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:
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:
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
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.
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.
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
1-800-452-0051
NDC 0067-2000-10
EXCEDRIN®
EXTRA STRENGTH
Acetaminophen, Aspirin (NSAID) and Caffeine
Pain Reliever/Pain Reliever Aid
10 CAPLETS
TAMPER-EVIDENT BOTTLE
DO NOT USE IF INNER FOIL SEAL INPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING
Distributed by: GSK Consumer Healthcare
Warren, NJ 07059
©2015 GSK or its licensor.
Visit us at
www.excedrin.com
46172146

| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 308297 | acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet | PSN | 12 |
| 209468 | EXCEDRIN 250 MG / 250 MG / 65 MG Oral Tablet | PSN | 12 |
| 209468 | acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet [Excedrin] | SBD | 12 |
| 308297 | acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet | SCD | 12 |
| 308297 | APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral Tablet | SY | 12 |
| 209468 | APAP 250 MG / ASA 250 MG / Caffeine 65 MG Oral Tablet [Excedrin] | SY | 12 |
| 209468 | Excedrin Extra Strength (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral Tablet | SY | 12 |
| 209468 | Excedrin Menstrual Complete (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral Tablet | SY | 12 |
| 209468 | Excedrin Migraine (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral Tablet | SY | 12 |
| Class | Version | Type | Effective |
|---|---|---|---|
| ASPIRIN Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20191108 |
| CAFFEINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0067-2000-02 | ExcedrinExtra Strength Pain Reliever | 2 in 1 POUCH | TABLET, FILM COATED | 2 | 12 | |
| 0067-2000-07 | ExcedrinExtra Strength Pain Reliever | 250 in 1 BOTTLE | TABLET, FILM COATED | 250 | 12 | |
| 0067-2000-10 | ExcedrinExtra Strength Pain Reliever | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | 12 | |
| 0067-2000-10 | ExcedrinExtra Strength Pain Reliever | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 12 | |
| 0067-2000-20 | ExcedrinExtra Strength Pain Reliever | 200 in 1 BOTTLE | TABLET, FILM COATED | 200 | 12 | |
| 0067-2000-20 | ExcedrinExtra Strength Pain Reliever | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 12 | |
| 0067-2000-24 | ExcedrinExtra Strength Pain Reliever | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 12 | |
| 0067-2000-24 | ExcedrinExtra Strength Pain Reliever | 24 in 1 BOTTLE | TABLET, FILM COATED | 24 | 12 | |
| 0067-2000-30 | ExcedrinExtra Strength Pain Reliever | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 12 | |
| 0067-2000-30 | ExcedrinExtra Strength Pain Reliever | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 12 | |
| 0067-2000-33 | ExcedrinExtra Strength Pain Reliever | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 12 | |
| 0067-2000-33 | ExcedrinExtra Strength Pain Reliever | 300 in 1 BOTTLE | TABLET, FILM COATED | 300 | 12 | |
| 0067-2000-50 | ExcedrinExtra Strength Pain Reliever | 50 in 1 BOTTLE | TABLET, FILM COATED | 50 | 12 | |
| 0067-2000-50 | ExcedrinExtra Strength Pain Reliever | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 12 | |
| 0067-2000-77 | ExcedrinExtra Strength Pain Reliever | 250 in 1 BOTTLE | TABLET, FILM COATED | 250 | 12 | |
| 0067-2000-77 | ExcedrinExtra Strength Pain Reliever | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 12 | |
| 0067-2000-83 | ExcedrinExtra Strength Pain Reliever | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 12 | |
| 0067-2000-83 | ExcedrinExtra Strength Pain Reliever | 125 in 1 BOTTLE | TABLET, FILM COATED | 125 | 12 | |
| 0067-2000-91 | ExcedrinExtra Strength Pain Reliever | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 12 | |
| 0067-2000-91 | ExcedrinExtra Strength Pain Reliever | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 12 | |
| 0067-2000-94 | ExcedrinExtra Strength Pain Reliever | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 12 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0067-2000 | EXCEDRIN EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE) TABLET, FILM COATED [HALEON US HOLDINGS LLC] | 12 | Current NDC, Legacy NDC, 21 package rows | 20240423_a71074a6-cc19-4bb3-8c84-4e82a8906801.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0067-2000-10 | EA - Each | 0067-2000 | adfcd816-2ed6-4c72-8c5d-908c9756ab3f | 1 | 2015-11-12 |
| 0067-2000-20 | EA - Each | 0067-2000 | cbff9d6a-ce12-4fbb-ac40-512a94ce514a | 1 | 2014-11-05 |
| 0067-2000-24 | EA - Each | 0067-2000 | 3de1f192-e5db-479d-84d8-19456b946402 | 1 | 2012-07-24 |
| 0067-2000-30 | EA - Each | 0067-2000 | 1f7e4f47-6c08-41f8-861c-981a7184f7a4 | 1 | 2025-05-14 |
| 0067-2000-33 | EA - Each | 0067-2000 | dcae665d-7d8d-4cfb-a2f9-93b577535a3e | 1 | 2015-10-02 |
| 0067-2000-50 | EA - Each | 0067-2000 | 9b6938a9-715c-431b-bada-71e78baeda03 | 1 | 2012-07-24 |
| 0067-2000-77 | EA - Each | 0067-2000 | 7d621095-87ef-450a-891e-067811771251 | 1 | 2012-07-24 |
| 0067-2000-91 | EA - Each | 0067-2000 | 51e263ed-40ca-4508-82dd-ccf0854b9b21 | 1 | 2012-07-24 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 6 | |
| ASPIRIN | ACTIVE INGREDIENT | R16CO5Y76E | 6 | |
| CAFFEINE | ACTIVE INGREDIENT | 3G6A5W338E | 6 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 6 | |
| ASPIRIN | ACTIVE MOIETY | R16CO5Y76E | 6 | |
| CAFFEINE | ACTIVE MOIETY | 3G6A5W338E | 6 | |
| BENZOIC ACID | INACTIVE INGREDIENT | 8SKN0B0MIM | 6 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | 6 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 6 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | 6 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 6 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | 6 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 6 | |
| LIGHT MINERAL OIL | INACTIVE INGREDIENT | N6K5787QVP | 6 | |
| POLYSORBATE 20 | INACTIVE INGREDIENT | 7T1F30V5YH | 6 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | 6 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 6 | |
| SORBITAN MONOLAURATE | INACTIVE INGREDIENT | 6W9PS8B71J | 6 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 6 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 6 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0067-2000 | 0067-2000-02, 0067-2000-10, 0067-2000-24, 0067-2000-30, 0067-2000-50, 0067-2000-91, 0067-2000-94, 0067-2000-83, 0067-2000-20, 0067-2000-77, 0067-2000-07, 0067-2000-33 |
Every source-derived ingredient row is available through these pages.
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, FILM COATED / ORAL | 96 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, FILM COATED / ORAL | 1 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | TABLET, FILM COATED / ORAL | NA | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, FILM COATED / ORAL | 1 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, FILM COATED / ORAL | 1 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED / ORAL | 582 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED / ORAL | 992 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, FILM COATED / ORAL | 0.16 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | TABLET, FILM COATED / ORAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| HYDROXYPROPYL CELLULOSE (TYPE H) | HYDROXYPROPYL CELLULOSE (1600000 WAMW) | RFW2ET671P | TABLET, FILM COATED / ORAL | 131.67 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, FILM COATED / ORAL | 1 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED / ORAL | 992 mg | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | TABLET, FILM COATED / ORAL | 2.49 mg | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | TABLET, FILM COATED / ORAL | 2.49 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | TABLET, FILM COATED / ORAL | NA | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | TABLET, FILM COATED / ORAL | NA | ||
| HYDROXYPROPYL CELLULOSE (TYPE H) | HYDROXYPROPYL CELLULOSE (1600000 WAMW) | RFW2ET671P | TABLET, FILM COATED / ORAL | 131.67 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET, FILM COATED / ORAL | 240 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | TABLET, FILM COATED / ORAL | 0.35 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | TABLET, FILM COATED / ORAL | 0.35 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, FILM COATED / ORAL | 96 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED / ORAL | 176 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET, FILM COATED / ORAL | 240 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET, FILM COATED / ORAL | 240 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | TABLET, FILM COATED / ORAL | 0.35 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET, FILM COATED / ORAL | 240 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED / ORAL | 582 mg | ||
| HYDROXYPROPYL CELLULOSE (TYPE H) | HYDROXYPROPYL CELLULOSE (1600000 WAMW) | RFW2ET671P | TABLET, FILM COATED / ORAL | 131.67 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, FILM COATED / ORAL | 1 mg | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | TABLET, FILM COATED / ORAL | 2.49 mg | ||
| SORBITAN MONOLAURATE | SORBITAN MONOLAURATE | 6W9PS8B71J | TABLET, FILM COATED / ORAL | 800 mg | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | TABLET, FILM COATED / ORAL | 2.49 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | TABLET, FILM COATED / ORAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, FILM COATED / ORAL | 0.16 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | TABLET, FILM COATED / ORAL | NA | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED / ORAL | 176 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED / ORAL | 992 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, FILM COATED / ORAL | 0.16 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED / ORAL | 176 mg | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | TABLET, FILM COATED / ORAL | 2.49 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED / ORAL | 992 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | TABLET, FILM COATED / ORAL | 0.35 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | TABLET, FILM COATED / ORAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, FILM COATED / ORAL | 0.16 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET, FILM COATED / ORAL | 240 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | TABLET, FILM COATED / ORAL | NA | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | TABLET, FILM COATED / ORAL | 2.49 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED / ORAL | 992 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, FILM COATED / ORAL | 0.16 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| SORBITAN MONOLAURATE | SORBITAN MONOLAURATE | 6W9PS8B71J | TABLET, FILM COATED / ORAL | 800 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, FILM COATED / ORAL | 96 mg | ||
| SORBITAN MONOLAURATE | SORBITAN MONOLAURATE | 6W9PS8B71J | TABLET, FILM COATED / ORAL | 800 mg | ||
| HYDROXYPROPYL CELLULOSE (TYPE H) | HYDROXYPROPYL CELLULOSE (1600000 WAMW) | RFW2ET671P | TABLET, FILM COATED / ORAL | 131.67 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET, FILM COATED / ORAL | 240 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | TABLET, FILM COATED / ORAL | 0.35 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, FILM COATED / ORAL | 0.16 mg |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Adverse event summaries are temporarily unavailable. Other product information remains available.