HEADACHE RELIEF EXTRA STRENGTH- acetaminophen, aspirin and caffeine tablet, film coated
CVS Pharmacy

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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CVS 44-159B

Active ingredients (in each tablet)

Acetaminophen 250 mg
Aspirin 250 mg (NSAID)*
Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever
Pain reliever
Pain reliever aid

Uses

temporarily relieves minor aches and pains due to:
- headache
- a cold
- arthritis
- muscular aches
- sinusitis
- toothache
- premenstrual and menstrual cramps

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: Aspirin may cause a severe allergic reaction, which may include:

hives
facial swelling
shock
asthma (wheezing)

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

more than 8 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

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 heartbeat.

Do not use

if you ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer
with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if

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 have asthma
you are taking a diuretic

Ask a doctor or pharmacist before use if you are

taking a prescription drug for diabetes, gout, or arthritis
taking any other drug or are under a doctor's care for any serious condition

Stop use and ask a doctor if

you experience any of the following signs of stomach bleeding:
- feel faint
- have bloody or black stools
- vomit blood
- have stomach pain that does not get better
an allergic reaction occurs. Seek medical help right away.
any new symptoms appear
ringing in the ears or loss of hearing occurs
pain gets worse or lasts for more than 10 days
fever gets worse or lasts for more than 3 days
painful area is red or swollen

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use aspirin during the last 3 months of 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 (1-800-222-1222) right away. 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
drink a full glass of water with each dose
adults and children 12 years and over
- take 2 tablets every 6 hours
- do not take more than 8 tablets in 24 hours
children under 12 years: ask a doctor

Other information

store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
see end flap for expiration date and lot number

Inactive ingredients

corn starch, crospovidone, hypromellose, microcrystalline cellulose, povidone, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

♥︎CVSHealth™

Compare to the active ingredients in
Excedrin® Extra Strength†

Coated Tablets
NDC 59779-915-59

EXTRA STRENGTH
Headache Relief

ACETAMINOPHEN, ASPIRIN (NSAID)
& CAFFEINE
Pain reliever / Pain reliever aid

Actual Size

275 TABLETS

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

†This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Excedrin® Extra Strength.
50844 ORG071315959

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2015 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
V-11112

PLEASE RECYCLE

√ CVS Quality
Money Back Guarantee
CVS 44-159B

CVS 44-159B

HEADACHE RELIEF EXTRA STRENGTH
acetaminophen, aspirin and caffeine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59779-915
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
HYPROMELLOSES (UNII: 3NXW29V3WO)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	44;159
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59779-915-15	1 in 1 CARTON	11/17/1992	04/19/2019
1		50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC:59779-915-08	1 in 1 CARTON	11/17/1992	04/19/2019
2		24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC:59779-915-11	1 in 1 CARTON	11/17/1992	04/19/2019
3		60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4	NDC:59779-915-12	1 in 1 CARTON	11/17/1992	04/19/2019
4		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
5	NDC:59779-915-59	1 in 1 CARTON	11/17/1992	07/08/2018
5		275 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part343	11/17/1992	04/19/2019

Labeler - CVS Pharmacy (062312574)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	MANUFACTURE(59779-915)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	PACK(59779-915)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	PACK(59779-915)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	PACK(59779-915)

Revised: 7/2017

Document Id: 17815ffb-d92b-43d1-8db8-cd419c3a7cd6

Set id: 151beb02-17a1-4fe8-9d54-668b00b5fbbe

Version: 9

Effective Time: 20170719

CVS Pharmacy