ACETAMINOPHEN ASPIRIN AND CAFFEINE- acetaminophen, aspirin and caffeine tablet, film coated

ACETAMINOPHEN ASPIRIN AND CAFFEINE by

Drug Labeling and Warnings

ACETAMINOPHEN ASPIRIN AND CAFFEINE by is a Otc medication manufactured, distributed, or labeled by Aurohealth LLC, APL HEALTHCARE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each tablet)

Acetaminophen USP 250 mg

Aspirin USP 250 mg (NSAID*)

Caffeine USP 65 mg

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever
Pain reliever
Pain reliever aid

Use

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 tablets 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 (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 tablets with a glass of water
• if symptoms persist or worsen, ask your doctor
• do not take more than 2 tablets in 24 hours, unless directed by a doctor
• under 18 years of age: ask a doctor

Other information

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

Inactive ingredients

crospovidone, glyceryl monostearate, low-substituted hydroxypropyl cellulose, microcrystalline cellulose, polyvinyl alcohol, povidone, pregelatinized starch (maize), sodium lauryl sulfate, stearic acid, talc and  titanium dioxide.

Questions or comments?

call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)

Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown Road,
East Windsor, NJ 08520

Made in India

Code: AP/DRUGS/04/2016

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg/250 mg/65 mg Container Label - 8 Tablets

AUROHEALTH
NDC: 58602-817-02

MIGRAINE RELIEF

Acetaminophen, Aspirin (NSAID)
and Caffeine Tablets USP
250 mg/250 mg/65 mg

Pain Reliever/
Pain Reliever Aid                            8 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg/250 mg/65 mg Container Carton Label - 8 Tablets

AUROHEALTH
NDC: 58602-817-02
**Compare to the active ingredients
of Excedrin® Migraine Relief

MIGRAINE RELIEF

Acetaminophen, Aspirin (NSAID)

and Caffeine Tablets USP

250 mg/250 mg/65 mg

Do not use if seal imprinted with
SEALED for YOUR PROTECTION under
the bottle cap is broken or missing.

Pain Reliever/Pain Reliever Aid                            8 Tablets

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN ASPIRIN AND CAFFEINE 
acetaminophen, aspirin and caffeine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58602-817
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
CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 2165RE0K14)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POVIDONE K30 (UNII: U725QWY32X)
POVIDONE K90 (UNII: RDH86HJV5Z)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE (White to off-White)	Score	no score
Shape	CAPSULE (biconvex)	Size	18mm
Flavor		Imprint Code	T;57
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58602-817-02	1 in 1 CARTON	02/02/2022
1		8 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 58602-817-03	1 in 1 CARTON	02/02/2022
2		10 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 58602-817-07	1 in 1 CARTON	02/02/2022
3		24 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 58602-817-09	1 in 1 CARTON	02/02/2022
4		30 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 58602-817-14	1 in 1 CARTON	02/02/2022
5		50 in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC: 58602-817-21	1 in 1 CARTON	02/02/2022
6		100 in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC: 58602-817-90	1 in 1 CARTON	02/02/2022
7		125 in 1 BOTTLE; Type 0: Not a Combination Product
8	NDC: 58602-817-34	200 in 1 BOTTLE; Type 0: Not a Combination Product	02/02/2022
9	NDC: 58602-817-36	250 in 1 BOTTLE; Type 0: Not a Combination Product	02/02/2022
10	NDC: 58602-817-38	300 in 1 BOTTLE; Type 0: Not a Combination Product	02/02/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA211695	02/02/2022

Labeler - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
APL HEALTHCARE LIMITED		650918514	ANALYSIS(58602-817) , MANUFACTURE(58602-817)