EXCEDRIN MIGRAINE- acetaminophen, aspirin and caffeine tablet, film coated 
Novartis Consumer Health, Inc.

----------

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?

1-800-468-7746

Distr. By:

Novartis Consumer Health, Inc.

Parsippany, NJ 07054-0622

Principal Display

EXCEDRIN MIGRAINE TABLETS

[Enter image caption here]

EXCEDRIN  MIGRAINE
acetaminophen, aspirin and caffeine tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0067-2037
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 (UNII: 3NXW29V3WO)  
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 ROUND (Capsule shaped tablet) Size 11mm
Flavor Imprint Code E
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0067-2037-02 2 in 1 PACKET
2 NDC:0067-2037-06 1 in 1 CARTON
2 6 in 1 BOTTLE
3 NDC:0067-2037-10 1 in 1 CARTON
3 10 in 1 BOTTLE
4 NDC:0067-2037-33 1 in 1 CARTON
4 300 in 1 BOTTLE
5 NDC:0067-2037-50 1 in 1 CARTON
5 50 in 1 BOTTLE
6 NDC:0067-2037-77 1 in 1 CARTON
6 250 in 1 BOTTLE
7 NDC:0067-2037-91 1 in 1 CARTON
7 100 in 1 BOTTLE
8 NDC:0067-2037-83 1 in 1 CARTON
8 125 in 1 BOTTLE
9 NDC:0067-2037-84 125 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020802 02/15/2010
Labeler - Novartis Consumer Health, Inc. (879821635)

Revised: 1/2010
Document Id: bdd243cd-972d-4ea5-9877-7b96d528a7e2
Set id: bdd243cd-972d-4ea5-9877-7b96d528a7e2
Version: 1
Effective Time: 20100101
 
Novartis Consumer Health, Inc.