PAIN RELIEVER EXTRA STRENGTH- acetaminophen tablet

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

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Active ingredient:
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)
Available from:
L.N.K. International, Inc.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever / fever reducer - temporarily relieves minor aches and pains due to: headache backache toothache the common cold minor pain of arthritis muscular aches premenstrual and menstrual cramps - headache - backache - toothache - the common cold - minor pain of arthritis - muscular aches - premenstrual and menstrual cramps - temporarily reduces fever
Authorization status:
OTC monograph not final
Authorization number:
50844-519-02, 50844-519-15

PAIN RELIEVER EXTRA STRENGTH- acetaminophen tablet

L.N.K. International, Inc.

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.

----------

Quality Plus 44-519

Active ingredient

(in each gelcap)

Acetaminophen 500 mg

Purpose

Pain reliever / fever reducer

Uses

temporarily relieves minor aches and pains due to:

headache

backache

toothache

the common cold

minor pain of arthritis

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

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.

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: Taking more than the recommended dose (overdose) may cause liver damage. 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 take more than directed (see overdose warning)

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: do not use this adult extra strength product in children under 12 years of

age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause

liver damage

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?

Call 1-800-426-9391

Principal Display Panel

QUALITY PLUS NDC 50844-519-02

*Compare to the active ingredient in Extra Strength TYLENOL Rapid Release

Gels

EXTRA STRENGTH

Pain Reliever

Acetaminophen 500 mg

12 Rapid Release Gelcaps Actual Size

PAIN RELIEVER/FEVER REDUCER

NON-ASPIRIN

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.

Distributed by LNK INTERNATIONAL, INC.

60 Arkay Drive, Hauppauge, NY 11788

USA 50844 REV0513D51902

Quality Plus 4 4 -519

PAIN RELIEVER EXTRA STRENGTH

acetaminophen tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:50 8 44-519

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D)

ACETAMINOPHEN

50 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

D&C RED NO . 3 3 (UNII: 9 DBA0 SBB0 L)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

GELATIN (UNII: 2G8 6 QN327L)

HYDRO XYPRO PYL CELLULO SE, UNSPECIFIED (UNII: 9 XZ8 H6 N6 OH)

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

PO VIDO NE (UNII: FZ9 8 9 GH9 4E)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

STARCH, CO RN (UNII: O8 232NY3SJ)

SHELLAC (UNII: 46 N10 7B71O)

Product Characteristics

Color

RED, BLUE

S core

no sco re

S hap e

OVAL

S iz e

19 mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:50 8 44-519 -

1 in 1 CARTON

0 5/10 /20 0 4

1

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

2

NDC:50 8 44-519 -

1 in 1 CARTON

0 5/10 /20 0 4

2

12 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

L.N.K. International, Inc.

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 5/10 /20 0 4

Labeler -

L.N.K. International, Inc. (038154464)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

0 38 15446 4

PACK(50 8 44-519 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 37

MANUFACTURE(50 8 44-519 ) , PACK(50 8 44-519 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

9 6 76 26 30 5

PACK(50 8 44-519 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 6 8 7340 8 8

PACK(50 8 44-519 )

Revised: 3/2020

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