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 Better Living Brands, LLC, 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: 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 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

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: 21130-074
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: 21130-074-07	1 in 1 CARTON	08/11/2023
1		24 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 21130-074-14	1 in 1 CARTON	08/11/2023
2		50 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 21130-074-21	1 in 1 CARTON	08/11/2023
3		100 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA211695	08/11/2023

Labeler - Better Living Brands, LLC (009137209)

Registrant - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
APL HEALTHCARE LIMITED		650918514	ANALYSIS(21130-074) , MANUFACTURE(21130-074)