PAIN RELIEF EXTRA STRENGTH- acetaminophen tablet
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 44-519 - Delisted

Active ingredient (in each gelcap)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to:
- headache
- the common cold
- backache
- minor pain of arthritis
- toothache
- muscular aches
- premenstrual and menstrual cramps
temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 gelcaps (3,000 mg) in 24 hours. 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:

skin reddening
blisters
rash

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

Do not use

if you are allergic to acetaminophen or any of the inactive ingredients in this product
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

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

pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
new symptoms occur
redness or swelling is present

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 (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs of symptoms.

Directions

do not take more than directed
adults and children 12 years and over
- take 2 gelcaps every 6 hours while symptoms last
- do not take more than 6 gelcaps in 24 hours, unless directed by a doctor
- do not take for more than 10 days unless directed by a doctor
children under 12 years: ask a doctor

Other information

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

Inactive ingredients

croscarmellose sodium, D&C red #33, FD&C blue #1, FD&C red #40, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

CVS Health™

Compare to the active ingredient in Extra
Strength Tylenol® Rapid Release Gels*

Rapid Release Gelcaps

NDC 59779-519-20

EXTRA STRENGTH
Pain Relief
ACETAMINOPHEN, 500 mg
Pain reliever, Fever reducer
Aspirin free

225 GELCAPS

RAPID
RELEASE

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 McNeil Consumer Healthcare,
owner of the registered trademark Extra Strength Tylenol® Rapid Release Gels.
50844 ORG061551920

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2017 CVS/pharmacy CVS.com®
1-800-SHOP CVS V-11112

√ CVS Quality
Money Back Guarantee

CVS Health 44-519

PAIN RELIEF EXTRA STRENGTH
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59779-519
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SHELLAC (UNII: 46N107B71O)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	RED, BLUE	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code	L;5
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59779-519-08	1 in 1 CARTON	05/10/2004	06/30/2020
1		24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC:59779-519-12	1 in 1 CARTON	05/10/2004	10/19/2017
2		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC:59779-519-15	1 in 1 CARTON	05/10/2004	10/19/2017
3		50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4	NDC:59779-519-20	1 in 1 CARTON	05/10/2004	06/30/2020
4		225 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
5	NDC:59779-519-05	400 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/10/2004	06/30/2020
6	NDC:59779-519-29	150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/10/2004	06/30/2020
7	NDC:59779-519-89	225 in 1 BOTTLE; Type 0: Not a Combination Product	05/10/2004	11/30/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part343	05/10/2004	06/30/2020

Labeler - CVS Pharmacy (062312574)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	MANUFACTURE(59779-519) , PACK(59779-519)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	PACK(59779-519)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	PACK(59779-519)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	PACK(59779-519)

Revised: 12/2020

Document Id: aa31065c-ac28-4882-a8d0-b88b9cdc8973

Set id: 115c48fc-82dd-4bc2-83ae-ffa95deaab3c

Version: 13

Effective Time: 20201204

CVS Pharmacy