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Excedrin Migraine Geltabs

Dosage form: tablet, coated
Ingredients: ACETAMINOPHEN 250mg, ASPIRIN 250mg, CAFFEINE 65mg
Labeler: Novartis Consumer Health, Inc
NDC Code: 0067-2035

Drug Facts

Active ingredients (in each geltab)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID)*

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever

Pain reliever

Pain reliever aid

Use
treats migraine

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 geltabs 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
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:
anticoagulation (thinning of the blood)
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
do not use more than directed
adults: take 2 geltabs with a glass of water
if symptoms persist or worsen, ask your doctor
do not take more than 2 geltabs in 24 hours, unless directed by a doctor
under 18 years of age: ask a doctor

Other information
store at controlled room temperature 20°-25°C (68°-77°F)
close cap tightly after use
read all product information before using. Keep this box for important information.

Inactive ingredients

benzoic acid, D&C yellow #10 aluminum lake, edetate disodium, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, gelatin, glycerin, hypromellose, iron oxide black, isopropyl alcohol, lactose monohydrate, light mineral oil, low-substituted hydroxypropyl cellulose, maltitol syrup, medium-chain triglycerides, microcrystalline cellulose, pepsin, polysorbate 20, povidone, propyl gallate, propylene glycol, simethicone, sorbitan monolaurate, stearic acid, titanium dioxide

Questions or comments?

1-800-468-7746

Package/Label Principal Display Panel
EXCEDRIN  MIGRAINE GELTABS
acetaminophen, asprin, caffeine tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-2035
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN250 mg
ASPIRIN (ASPIRIN) ASPIRIN250 mg
CAFFEINE (CAFFEINE) CAFFEINE65 mg
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID 
D&C YELLOW NO. 10 
EDETATE DISODIUM 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
FERRIC OXIDE RED 
GELATIN 
GLYCERIN 
HYPROMELLOSES 
FERROSOFERRIC OXIDE 
ISOPROPYL ALCOHOL 
LACTOSE MONOHYDRATE 
LIGHT MINERAL OIL 
HYDROXYPROPYL CELLULOSE (TYPE H) 
MALTITOL 
MEDIUM-CHAIN TRIGLYCERIDES 
CELLULOSE, MICROCRYSTALLINE 
PEPSIN 
POLYSORBATE 20 
POVIDONES 
PROPYL GALLATE 
PROPYLENE GLYCOL 
DIMETHICONE 
SORBITAN MONOLAURATE 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorGREEN (dark green) , WHITEScoreno score
ShapeROUNDSize18mm
FlavorImprint CodeE
Contains    
Packaging
#Item CodePackage Description
1NDC:0067-2035-201 BOTTLE in 1 CARTON
120 TABLET, COATED in 1 BOTTLE
2NDC:0067-2035-241 BOTTLE in 1 CARTON
224 TABLET, COATED in 1 BOTTLE
3NDC:0067-2035-501 BOTTLE in 1 CARTON
350 TABLET, COATED in 1 BOTTLE
4NDC:0067-2035-801 BOTTLE in 1 CARTON
480 TABLET, COATED in 1 BOTTLE
5NDC:0067-2035-912 BOTTLE in 1 CARTON
5100 TABLET, COATED in 1 BOTTLE
6NDC:0067-2035-162 BOTTLE in 1 CARTON
6160 TABLET, COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02080209/13/2011
Labeler - Novartis Consumer Health, Inc (879821635)

Revised: 08/2015
 
Novartis Consumer Health, Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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