Label: EXCEDRIN MIGRAINE (acetaminophen, aspirin- nsaid and caffeine tablet, film coated
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Contains inactivated NDC Code(s)
NDC Code(s): 53808-0835-1 - Packager: State of Florida DOH Central Pharmacy
- This is a repackaged label.
- Source NDC Code(s): 0067-2039
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated September 11, 2013
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- 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: 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 tablets 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
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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
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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
- If pregnant or breast-feeding
- Keep Out of Reach of Children
- Directions
- Other information
- Inactive Ingredients
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Questions or comments?
This product is supplied by State of Florida DOH Central Pharmacy as follows:
NDC Strength Quantity/Form Color Source Prod. Code 53808-0835-1 250 mg / 250 mg / 65 mg 30 Tablets in a Blister Pack White 0067-2039 This product was distributed By:
Novartis Consumer Health, Inc.
Parsippany, NJ 07054-0622
1-800-468-7746
And Repackaged By:
State of Florida DOH Central Pharmacy
104-2 Hamilton Park Drive
Tallahassee, FL 32304
United States
- Principal Display
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INGREDIENTS AND APPEARANCE
EXCEDRIN MIGRAINE
acetaminophen, aspirin (nsaid) and caffeine tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53808-0835(NDC:0067-2039) 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) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P) HYPROMELLOSE 2208 (100000 MPA.S) (UNII: VM7F0B23ZI) LIGHT MINERAL OIL (UNII: N6K5787QVP) 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 (White) Score no score Shape CAPSULE (Capsule shaped tablet) Size 18mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53808-0835-1 30 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020802 01/01/2013 Labeler - State of Florida DOH Central Pharmacy (829348114) Establishment Name Address ID/FEI Business Operations State of Florida DOH Central Pharmacy 829348114 repack(53808-0835)