ACETAMINOPHEN ASPIRIN CAFFEINE- acetaminophen aspirin caffeine tablet 
CVS PHARMACY, INC

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Migraine Relief

ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE TABLETS, USP

PAIN RELIEVER/PAIN RELIVER 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

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 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 room temperature 20° to 25°C (68° to 77°F)
■ close cap tightly after use
■ read all product information before using.

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

100 ct

ACETAMINOPHEN ASPIRIN CAFFEINE 
acetaminophen aspirin caffeine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-680
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 mg
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULE (Capsule shaped Tablet) Size17mm
FlavorImprint Code I1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-680-10100 in 1 BOTTLE; Type 0: Not a Combination Product07/05/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21403907/05/2021
Labeler - CVS PHARMACY, INC (062312574)

Revised: 12/2023
Document Id: 0ce259b1-3dc4-177f-e063-6294a90a29d0
Set id: c340c5ef-e15d-53ce-e053-2995a90a73e7
Version: 4
Effective Time: 20231219
 
CVS PHARMACY, INC