![EXCEDRIN EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET [NAVAJO MANUFACTURING COMPANY INC.]](https://medic.hrt.org//dailymed/images/14bec07c-438e-4fdd-8131-8ecd484e81c6/26708.jpg)
![EXCEDRIN EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET [NAVAJO MANUFACTURING COMPANY INC.]](https://medic.hrt.org//dailymed/images/14bec07c-438e-4fdd-8131-8ecd484e81c6/Excedrin.jpg)
| NDC | 67751-141-01, 67751-141-02 |
| Set ID | 14bec07c-438e-4fdd-8131-8ecd484e81c6 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Navajo Manufacturing Company Inc. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART343 |
- Drug Facts
- Active ingredients (in each caplet)
- Uses
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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 productStomach 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 pharmacistAsk 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 asthmaAsk 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 conditionStop 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
- Questions or comments?
- Package Labeling:
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INGREDIENTS AND APPEARANCE
EXCEDRIN EXTRA STRENGTH
acetaminophen, aspirin, caffeine tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67751-141(NDC:0067-2000) 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) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) LIGHT MINERAL OIL (UNII: N6K5787QVP) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYSORBATE 20 (UNII: 7T1F30V5YH) POVIDONE (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:67751-141-01 1 in 1 CARTON 09/16/2016 1 2 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:67751-141-02 2 in 1 CARTON 09/16/2016 2 4 in 1 POUCH; Type 0: Not a Combination Product 3 NDC:67751-141-03 12 in 1 BOX 01/22/2018 3 1 in 1 POUCH; Type 0: Not a Combination Product 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 Business Operations Navajo Manufacturing Company Inc. 136941411 relabel(67751-141)
