ACETAMINOPHEN, ASPIRIN AND CAFFEINE tablet

Acetaminophen, Aspirin and Caffeine by

Drug Labeling and Warnings

Acetaminophen, Aspirin and Caffeine by is a Otc medication manufactured, distributed, or labeled by FAMILY DOLLAR. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN, ASPIRIN AND CAFFEINE 
acetaminophen, aspirin and caffeine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-680
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	250 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	65 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	250 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score	no score
Shape	CAPSULE ((Capsule shaped Tablet))	Size	17mm
Flavor		Imprint Code	I1
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55319-680-10	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA214039	09/01/2023

Labeler - FAMILY DOLLAR (024472631)