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:

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:

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

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

Ask a doctor before use if

Ask a doctor or pharmacist before use if you are

Stop use and ask a doctor if

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 - 100 Tablets

Healthy Living

ACETAMINOPHEN,
ASPIRIN (NSAID)
AND CAFFEINE
tablets USP, 250 mg/250 mg/65 mg

Pain Reliever/Pain Reliever Aid
100 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg/250 mg/65 mg Container Label - 100 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg/250 mg/65 mg Container Carton Label - 100 Tablets

Healthy Living
ACETAMINOPHEN, ASPIRIN (NSAID)
AND CAFFEINE
tablets USP, 250 mg/250 mg/65 mg

**Compare
to the Active
Ingredients of
Excedrin®
Migraine

Pain Reliever/Pain Reliever Aid                            100 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:58602-882
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:58602-882-211 in 1 CARTON06/23/2022
1100 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:58602-882-381 in 1 CARTON06/23/2022
2300 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21169506/23/2022
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
APL HEALTHCARE LIMITED650918514ANALYSIS(58602-882) , MANUFACTURE(58602-882)

Revised: 12/2023
Document Id: 20f3adf2-9058-4420-ac3b-1da54420a1d2
Set id: f5465419-1453-4ccc-a517-1fdff1eb3c05
Version: 3
Effective Time: 20231201
 
Aurohealth LLC