Active ingredients (in each caplet)

Acetaminophen 500 mg
(formulated with 65 mg caffeine)

Purpose

Pain reliever

Uses

temporarily relieves minor aches and pains due to:
- headache
- muscular aches

Warnings

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

more than 4,000 mg of acetaminophen in 24 hours
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

blisters
rash
skin reddening

If a skin reaction occurs, stop use and seek medical help right away.

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

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
if you are allergic to acetaminophen

Ask a doctor before use if you have

liver disease.

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

Stop use and ask a doctor if

new symptoms occur
painful area is red or swollen
pain gets worse or lasts for more than 10 days
fever gets worse or lasts for more than 3 days

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

do not take more than directed
adults and children 12 years and over: take 2 caplets every 6 hours. Do not take more than 6 caplets in 24 hours.
children under 12 years: ask a doctor

Other information

store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
use by expiration date on package

Inactive ingredients

corn starch, crospovidone, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

♥CVS
Health™

Compare to the active ingredients
in Excedrin® Tension Headache*

Coated Caplets

Aspirin Free
Tension Headache

ACETAMINOPHEN
& CAFFEINE
Pain reliever

100 CAPLETS

Actual Size

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

*This product is not manufactured or distributed by GSK Consumer Healthcare S.A.,
owner of the registered trademark Excedrin® Tension Headache.

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2020 CVS/pharmacy CVS.com®
1-800-SHOP CVS V-11112

50844
REV1119A42812

CVS 44-428

TENSION HEADACHE ASPIRIN FREE
acetaminophen, caffeine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59779-824
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	65 mg

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN (UNII: O8232NY3SJ)
CROSPOVIDONE (UNII: 2S7830E561)
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)
FD&C BLUE NO. 2 ALUMINUM LAKE (UNII: 4AQJ3LG584)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	17mm
Flavor		Imprint Code	44;428
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59779-824-21	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/17/2007
2	NDC:59779-824-06	200 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/17/2007
3	NDC:59779-824-08	1 in 1 CARTON	01/17/2007	12/01/2024
3		24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4	NDC:59779-824-12	1 in 1 CARTON	01/17/2007	02/11/2018
4		100 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 Drug	M013	01/17/2007

Labeler - CVS Pharmacy (062312574)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(59779-824)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	manufacture(59779-824)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	pack(59779-824)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(59779-824)