ACETAMINOPHEN ASPIRIN AND CAFFEINE - acetaminophen, aspirin and caffeine tablet, film coated 
Better Living Brands, LLC

----------

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

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:
BETTER LIVING BRANDS LLC
P.O.BOX 99, PLEASANTON, CA 94566-0009
1-888-723-3929

Made in India

Code: AP/DRUGS/04/2016

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg/250 mg/65 mg Container Label - 24 Tablets

Signature                        NDC 21130-074-07
Care®
Quality Guaranteed

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

Pain Reliever/Pain Reliever Aid
24 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 - 24 Tablets

Signature
Care®
Quality Guaranteed

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

Compare to the active ingredients of Excedrin® Migraine Relief**

NDC 21130-074-07

Migraine Relief
Acetaminophen, Aapirin (NSAID)
and Caffeine Tablets USP
250 mg/250 mg/65 mg

Actual Size

Pain Reliever/Pain Reliever Aid                            24 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:21130-074
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:21130-074-071 in 1 CARTON08/11/2023
124 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:21130-074-141 in 1 CARTON08/11/2023
250 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:21130-074-211 in 1 CARTON08/11/2023
3100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21169508/11/2023
Labeler - Better Living Brands, LLC (009137209)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
APL HEALTHCARE LIMITED650918514ANALYSIS(21130-074) , MANUFACTURE(21130-074)

Revised: 8/2023
Document Id: 068e2ba0-2db2-4c12-ad9e-47a7130c2a22
Set id: f8050cae-8619-f49b-e053-6294a90ad9e6
Version: 2
Effective Time: 20230817
 
Better Living Brands, LLC