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 Safrel Pharmaceuticals, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT(S)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID*)

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

PURPOSE

Pain reliever

Pain reliever

Pain reliever aid

USE(S)

• 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 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

taking a prescription drug for:

o diabetes

o gout

o 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 DOCTOR IF

an allergic reaction occurs. Seek medical help right away.

you experience any of the following signs of stomach bleeding :

o feel faint

o vomit blood

o have bloody or black stools

o 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 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.

Tamper Evident : Do not use if foil inner seal under the cap is opened or missing

INACTIVE INGREDIENTS

Carnauba wax, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, propylene glycol, sodium stearyl fumarate and titanium dioxide

QUESTIONS OR COMMENTS?

Contact 1-844-384-3273 Mon-Fri 8:00 AM EST to 5:00 PM PST


Distributed By:

Safrel Pharmaceuticals, LLC

Bridgewater, NJ 08807

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN, ASPIRIN AND CAFFEINE 
acetaminophen, aspirin and caffeine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71309-079
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CARNAUBA WAX (UNII: R12CBM0EIZ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)

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: 71309-079-03	300 in 1 BOTTLE; Type 0: Not a Combination Product	04/15/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA214039	04/15/2021

Labeler - Safrel Pharmaceuticals, LLC. (080566287)