EXCEDRIN MIGRAINE- acetaminophen, aspirin, and caffeine tablet, film coated 
Lil' Drug Store Products, Inc.

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Excedrin® Migraine

Drug Facts

Active ingredients (in each caplet)Purposes
*
nonsteroidal anti-inflammatory drug
Acetaminophen 250 mgPain reliever
Aspirin 250 mg (NSAID*)Pain reliever
Caffeine 65 mgPain reliever aid

Use

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 2 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 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

Medication overuse headache warning

Headaches may worsen if this product is used for 10 or more days per month.

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 pharmacist

Ask a 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

  • taking a prescription drug for:
    • diabetes
    • gout
    • arthritis
  • under a doctor's care for any serious condition
  • taking any other drug
  • taking any other product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer

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, 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

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?

1-800-468-7746

Packaged and distributed by Lil' Drug Store Products, Inc., 9300 Earhart Ln SW, Cedar Rapids, IA

PRINCIPAL DISPLAY PANEL - 6 Caplet Packet Carton

See new warnings information

EXCEDRIN®

MIGRAINE
Acetaminophen, Aspirin (NSAID) and Caffeine
Pain Reliever / Pain Reliever Aid

6 Caplets
3 PACKETS OF 2 CAPLETS
*CAPSULE-SHAPED TABLETS

Lil'
DrugStore®

PRINCIPAL DISPLAY PANEL - 6 Caplet Packet Carton
EXCEDRIN MIGRAINE 
acetaminophen, aspirin, and caffeine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-9749
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen250 mg
Aspirin (UNII: R16CO5Y76E) (Aspirin - UNII:R16CO5Y76E) Aspirin250 mg
Caffeine (UNII: 3G6A5W338E) (Caffeine - UNII:3G6A5W338E) Caffeine65 mg
Inactive Ingredients
Ingredient NameStrength
Benzoic Acid (UNII: 8SKN0B0MIM)  
Carnauba Wax (UNII: R12CBM0EIZ)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
FD&C Blue No. 1 (UNII: H3R47K3TBD)  
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
Hypromellose, Unspecified (UNII: 3NXW29V3WO)  
Light Mineral Oil (UNII: N6K5787QVP)  
Polysorbate 20 (UNII: 7T1F30V5YH)  
Povidone, Unspecified (UNII: FZ989GH94E)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Sorbitan Monolaurate (UNII: 6W9PS8B71J)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITEScoreno score
ShapeOVAL (Capsule shaped tablet) Size18mm
FlavorImprint Code E
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66715-9749-33 in 1 CARTON08/15/2019
12 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02080208/15/2019
Labeler - Lil' Drug Store Products, Inc. (093103646)

Revised: 8/2019
Document Id: ada417cb-5fa9-4f93-8107-33cb2b8ce88e
Set id: 40aeb2c5-a37b-446d-9918-8378a75ff327
Version: 1
Effective Time: 20190809
 
Lil' Drug Store Products, Inc.