ACETAMINOPHEN, ASPIRIN AND CAFFEINE- acetaminophen, aspirin and caffeine tablet 
FAMILY DOLLAR

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Migraine Relief
Acetaminophen, Aspirin and Caffeine Tablets, USP 250mg, 250mg and 65mg

Pain Reliever/ Pain Reliever Aid

Active ingredients (in each caplet)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID*)
Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever

Pain reliever aid

Use

treats migraine

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 at 20 weeks or later in 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 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 controlled room temperature 20° to 25°C (68° to 77°F)
• close cap tightly after use
• read all product information before using.
Keep this box for important information.

Inactive ingredients:

carnauba wax, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol, sodium stearyl fumarate and titanium dioxide

Questions or comments?

contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST

PDP

Migraine 100ct

ACETAMINOPHEN, ASPIRIN AND CAFFEINE 
acetaminophen, aspirin and caffeine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-680
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULE ((Capsule shaped Tablet)) Size17mm
FlavorImprint Code I1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55319-680-10100 in 1 BOTTLE; Type 0: Not a Combination Product09/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21403909/01/2023
Labeler - FAMILY DOLLAR (024472631)

Revised: 12/2023
Document Id: 0c521000-16c9-c8b7-e063-6394a90ae9b4
Set id: f837e190-6fb3-e22e-e053-6394a90a12e6
Version: 3
Effective Time: 20231212
 
FAMILY DOLLAR