ACETAMINOPHEN tablet

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

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Active ingredient:
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)
Available from:
Target Corporation
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:
11673-148-08

ACETAMINOPHEN- acetaminophen tablet

Target Corporation

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.

----------

Target 44-148-Delisted

Active ingredient (in each tablet)

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

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.

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 tablets every 6 hours while symptoms last

do not take more than 6 tablets 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 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

see end flap for expiration date and lot number

Inactive ingredients

corn starch, povidone, sodium starch glycolate, stearic acid

Questions or comments?

Call 1-800-910-6874

Principal display panel

NDC 11673-148-08

Compare to active ingredient

in Extra Strength Tylenol®*

extra strength

acetaminophen

tablets, 500 mg

pain reliever/fever reducer

contains no aspirin

24 TABLETS

24 TABLETS

ACTUAL SIZE

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the

registered trademark Extra Strength Tylenol®.

50844 ORG061714808

Distributed by Target Corporation

Minneapolis, MN 55403

TM & ©2019 Target Brands, Inc.

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

BROKEN OR MISSING

Targ et 4 4 -14 8

ACETAMINOPHEN

acetaminophen tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:116 73-148

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

STARCH, CO RN (UNII: O8 232NY3SJ)

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

SO DIUM STARCH GLYCO LATE TYPE A PO TATO (UNII: 58 56 J3G2A2)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

Product Characteristics

Color

WHITE

S core

no sco re

S hap e

ROUND

S iz e

12mm

Flavor

Imprint Code

44;148

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:116 73-148 -

1 in 1 CARTON

0 4/0 1/20 19

10 /0 8 /20 22

1

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

Pro duc t

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 4/0 1/20 19

10 /0 8 /20 22

Labeler -

T arget Corporation (006961700)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 37

MANUFACTURE(116 73-148 )

Target Corporation

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

0 38 15446 4

PACK(116 73-148 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 6 8 7340 8 8

PACK(116 73-148 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

9 6 76 26 30 5

PACK(116 73-148 )

Revised: 12/2019

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