TYLENOL EXTRA STRENGTH- acetaminophen tablet, film coated

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Acetaminophen (UNII: 362O9ITL9D) (acetaminophen - UNII:362O9ITL9D)
Available from:
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever/fever reducer - temporarily relieves minor aches and pains due to: the common cold headache backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps - the common cold - headache - backache - minor pain of arthritis - toothache - muscular aches - premenstrual and menstrual cramps - temporarily reduces fever
Authorization status:
OTC monograph not final
Authorization number:
50580-937-01, 50580-937-02, 50580-937-03, 50580-937-04, 50580-937-05, 50580-937-06, 50580-937-07, 50580-937-10, 50580-937-15, 50580-937-19, 50580-937-20

TYLENOL EXTRA STRENGTH- acetaminophen tablet, film coated

Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

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.

----------

Tylenol

Extra Strength

Drug Facts

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpos e

Pain reliever/fever reducer

Us es

temporarily relieves minor aches and pains due to:

the common cold

headache

backache

minor pain of arthritis

toothache

muscular aches

premenstrual and menstrual cramps

temporarily reduces fever

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:

skin reddening

blisters

rash

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

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 or any of the inactive ingredients in this product

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.

Overdose warning

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 take more than directed (see overdose warning)

adults and

children 12 years

and over

take 2 caplets every 6 hours while

symptoms last

do not take more than 6 caplets in 24

hours, unless directed by a doctor

do not use for more than 10 days unless

directed by a doctor

children under 12

years

ask a doctor

Other information

store between 20-25°C (68-77°F)

do not use if carton is opened. Do not use if foil inner seal imprinted with "TYLENOL" is

broken or missing

Inactive ingredients

carnauba wax , corn starch , FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate,

modified starch , polyethylene glycol

, powdered cellulose, pregelatinized starch, propylene glycol,

shellac, sodium starch glycolate, titanium dioxide

Questions or comments?

call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL

NDC 50580-937-07

contains one or more of these ingredients

TYLENOL

FOR ADULTS

Acetaminophen

Pain Reliever

Fever Reducer

Extra Strength

Actual Size

100 Caplets

500 mg each

TYLENOL EXTRA STRENGTH

acetaminophen tablet, film coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:50 58 0 -9 37

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Aceta mino phen (UNII: 36 2O9 ITL9 D) (acetamino phen - UNII:36 2O9 ITL9 D)

Ac e ta mino phe n

50 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

ca rna uba wa x (UNII: R12CBM0 EIZ)

sta rch, co rn (UNII: O8 232NY3SJ)

FD&C red no . 4 0 (UNII: WZB9 127XOA)

a luminum o xide (UNII: LMI26 O6 9 33)

hypro mello se, unspecified (UNII: 3NXW29 V3WO)

ma g nesium stea ra te (UNII: 70 0 9 7M6 I30 )

po lyethylene g lyco l, unspecified (UNII: 3WJQ0 SDW1A)

po wdered cellulo se (UNII: SMD1X3XO9 M)

pro pylene g lyco l (UNII: 6 DC9 Q16 7V3)

shella c (UNII: 46 N10 7B71O)

so dium sta rch g lyco la te type a po ta to (UNII: 58 56 J3G2A2)

tita nium dio xide (UNII: 15FIX9 V2JP)

Product Characteristics

Color

WHITE

S core

no sco re

S hap e

OVAL

S iz e

19 mm

Flavor

Imprint Code

TYLENOL;50 0

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:50 58 0 -9 37-0 1

12 in 1 PACKAGE

0 8 /19 /20 19

1

10 in 1 VIAL; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:50 58 0 -9 37-0 2

12 in 1 PACKAGE

0 9 /16 /20 19

2

10 in 1 VIAL; Type 0 : No t a Co mbinatio n Pro duct

3

NDC:50 58 0 -9 37-0 3

2 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

0 7/31/20 20

4

NDC:50 58 0 -9 37-0 4

3 in 1 CARTON

0 7/31/20 20

4

2 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

5

NDC:50 58 0 -9 37-0 5

50 in 1 CARTON

0 7/31/20 20

5

2 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

6

NDC:50 58 0 -9 37-20

50 in 1 CARTON

0 7/31/20 20

6

2 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

7

NDC:50 58 0 -9 37-0 6

1 in 1 CARTON

0 8 /31/20 20

7

24 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

8

NDC:50 58 0 -9 37-10

1 in 1 CARTON

0 8 /31/20 20

8

50 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

9

NDC:50 58 0 -9 37-0 7

1 in 1 CARTON

0 8 /31/20 20

9

10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

10

NDC:50 58 0 -9 37-15

1 in 1 CARTON

0 8 /31/20 20

10

225 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

11

NDC:50 58 0 -9 37-19

325 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 8 /31/20 20

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH NOT FINAL part343

0 8 /19 /20 19

Labeler -

Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)

Revised: 7/2020

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