MIGRAINE FORMULA- acetaminophen, aspirin and caffeine tablet 
Western Family Foods Inc

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Western Family Migraine Formula Drug Facts

Active ingredient (in each caplet)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID*)

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Pain reliever aid

Uses

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: 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

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. (1-800-222-1222) 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 caplets with a glass of water
if symptoms persist or worsen, ask your doctor
do not take more than 2 caplets in 24 hours, unless directed by a doctor
under 18 years of age: ask a doctor

Other information

store at 20°-25°C (68°-77°F)
read all product information before using. Keep this box for important information.

Inactive ingredients

carnauba wax, crospovidone, FD&C blue #1 aluminum lake, hypromellose, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, saccharin sodium, stearic acid, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

SEE NEW WARNINGS INFORMATION

Migraine Formula

ACETAMINOPHEN, ASPIRIN (NSAID) & CAFFEINE TABLETS

PAIN RELIEVER - PAIN RELIEVER AID

Gluten Free

COMPARE TO EXCEDRIN® MIGRAINE active ingredients

†Capsule-Shaped Tablets

Migraine Formula Carton Image
MIGRAINE FORMULA 
acetaminophen, aspirin, caffeine tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:55312-374
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
CARNAUBA WAX 
CROSPOVIDONE 
HYPROMELLOSES 
CELLULOSE, MICROCRYSTALLINE 
POVIDONES 
PROPYLENE GLYCOL 
SACCHARIN SODIUM 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize17mm
FlavorImprint Code L374
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55312-374-621 in 1 CARTON
124 in 1 BOTTLE
2NDC:55312-374-781 in 1 CARTON
2100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07579410/04/2002
Labeler - Western Family Foods Inc (192166072)

Revised: 4/2013
Document Id: 7db86ccd-e085-4e1b-8fad-0dbf9b38175a
Set id: b89784cf-8515-4254-ae4c-eff9b7667620
Version: 3
Effective Time: 20130421
 
Western Family Foods Inc