EXCEDRIN MIGRAINE- acetaminophen, aspirin (nsaid) and caffeine tablet, film coated 
State of Florida DOH Central Pharmacy

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Drug Facts

Active ingredient

Acetaminophen 250 mg

Aspirin 250 mg (NSAID) *

Caffeine 65 mg

* nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Pain reliever

Pain reliever aid

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: 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.

Do not use

Ask Doctor before use if

Ask a doctor or pharmacist before use if you are

Stop use and ask a doctor if

If pregnant or breast-feeding

ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep Out of Reach of Children

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.

Directions

Other information

TAMPER-EVIDENT BOTTLE

DO NOT USE IF INNER FOIL SEAL IMPRINTED WITH

“SEALED for YOUR PROTECTION”IS BROKEN OR MISSING

 

Inactive Ingredients

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

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

EXCEDRIN MIGRAINE CAPLETS

EXCEDRIN  MIGRAINE
acetaminophen, aspirin (nsaid) and caffeine tablet, film coated
Product 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)

Revised: 9/2013
Document Id: b7ef153b-d459-49e9-ac4a-c7744a7fc9ed
Set id: 540c34a3-a4dc-4dd7-8ef9-53092b7a86bb
Version: 1
Effective Time: 20130911
 
State of Florida DOH Central Pharmacy