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:
FRED'S, INC.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever/fever reducer - temporarily relieves minor aches and pains due to: headache the common cold backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps - headache - the common cold - backache - minor pain of arthritis - toothache - muscular aches - premenstrual and menstrual cramps - temporarily reduces fever
Authorization status:
OTC monograph not final
Authorization number:
55315-519-12, 55315-519-15

PAIN RELIEVER EXTRA STRENGTH- acetaminophen tablet

FRED'S, 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.

----------

Freds Pharmacy 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. 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

new symptoms occur

pain gets worse or lasts more than 10 days

fever gets worse or lasts more than 3 days

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 or 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 15°-30°C (59°-86°F)

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

fred's

Pharmacy

NDC 55315-519-12

EXTRA STRENGTH

PAIN RELIEVER

ACETAMINOPHEN, 500 mg

Pain Reliever/Fever Reducer

ACTUAL SIZE

RAPID RELEASE

100 GELCAPS

Compare To The Active Ingredient in

Extra Strength TYLENOL® Rapid Release Gels*

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY

SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by Johnson & Johnson

Corporation, owner of the registered trademark Extra Strength Tylenol®

Rapid Release Gels.

50844 REV0417F51912

DISTRIBUTED BY: fred's, Inc.

4300 NEW GETWELL RD, MEMPHIS, TN 38118

www.freds inc.com

100%

s atis faction

guaranteed

Questions or comments:

1-855-331-FRED (3733)

Freds 4 4 -519

PAIN RELIEVER EXTRA STRENGTH

acetaminophen tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:55315-519

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, UNSPECIFIED (UNII: 2G8 6 QN327L)

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

HYPRO MELLO SE, UNSPECIFIED (UNII: 3NXW29 V3WO)

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

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

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

PO VIDO NE, UNSPECIFIED (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)

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

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:55315-519 -15

1 in 1 CARTON

0 5/10 /20 0 4

0 4/0 8 /20 22

1

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

2

NDC:55315-519 -12

1 in 1 CARTON

0 5/10 /20 0 4

0 4/0 8 /20 22

2

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

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

0 4/0 8 /20 22

Labeler -

FRED'S, INC. (005866116)

FRED'S, INC.

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

0 38 15446 4

PACK(55315-519 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 37

MANUFACTURE(55315-519 ) , PACK(55315-519 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

9 6 76 26 30 5

PACK(55315-519 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 6 8 7340 8 8

PACK(55315-519 )

Revised: 6/2020

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