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

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Acetaminophen, Aspirin (NSAID) and Caffeine Tablets USP

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

Other 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
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 Label - 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

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


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

ACETAMINOPHEN ASPIRIN AND CAFFEINE 
acetaminophen, aspirin and caffeine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-817
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITE (White to off-White) Scoreno score
ShapeCAPSULE (biconvex) Size18mm
FlavorImprint Code T;57
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58602-817-021 in 1 CARTON02/02/2022
18 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:58602-817-031 in 1 CARTON02/02/2022
210 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:58602-817-071 in 1 CARTON02/02/2022
324 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:58602-817-091 in 1 CARTON02/02/2022
430 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:58602-817-141 in 1 CARTON02/02/2022
550 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:58602-817-211 in 1 CARTON02/02/2022
6100 in 1 BOTTLE; Type 0: Not a Combination Product
7NDC:58602-817-901 in 1 CARTON02/02/2022
7125 in 1 BOTTLE; Type 0: Not a Combination Product
8NDC:58602-817-34200 in 1 BOTTLE; Type 0: Not a Combination Product02/02/2022
9NDC:58602-817-36250 in 1 BOTTLE; Type 0: Not a Combination Product02/02/2022
10NDC:58602-817-38300 in 1 BOTTLE; Type 0: Not a Combination Product02/02/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21169502/02/2022
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
APL HEALTHCARE LIMITED650918514ANALYSIS(58602-817) , MANUFACTURE(58602-817)

Revised: 5/2022
Document Id: fe6d56ff-f11a-43e6-b027-5943a5ee7d6d
Set id: e47e2169-4b31-4c23-bb9d-c26aa106ea37
Version: 2
Effective Time: 20220513
 
Aurohealth LLC