PLUSPHARMA EXTRA STRENGTH PAIN RELIEVER,FEVER REDUCER 500 MG- acetaminophen tablet

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

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Active ingredient:
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)
Available from:
NuCare Pharmaceuticals,Inc.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever/fever reducer - for the temporary relief of minor aches and pains due to: -     headache -     muscular aches -     backache -     minor pain of arthritis -     the common cold -     toothache -     premenstrual and menstrual cramps -     temporarily reduces fever
Authorization status:
OTC monograph not final
Authorization number:
68071-4339-3, 68071-4339-9

PLUSPHARMA EXTRA STRENGTH PAIN RELIEVER,FEVER REDUCER 500 MG-

acetaminophen tablet

NuCare Pharmaceuticals,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.

----------

Drug Facts

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpos es

Pain reliever/fever reducer

Us es

for the temporary relief of minor aches and pains due to:

headache

muscular aches

backache

minor pain of arthritis

the common cold

toothache

premenstrual and menstrual cramps

temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6

caplets (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 non prescription). 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

These could be signs of a serious condition.

pain gets worse or lasts more than 10 days

fever gets worse or lasts more than 3 days

new symptoms occur

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

the 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 take for more than 10 days unless directed by a doctor

Children under 12 years: ask a doctor

Other information

Do not use if imprinted safety seal under cap is broken or missing.

Store at room temperature

Inactive ingredients

Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid.

Ques tions ?

If you have any questions or comments, or to report an adverse event, please contact (800) 795-9775.

Principal Display Panel

PLUSPHARMA EXTRA STRENGTH PAIN RELIEVER,FEVER REDUCER 500

MG

acetaminophen tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 8 0 71-4339 (NDC:516 45-70 5)

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

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

STARCH, CO RN (UNII: O8 232NY3SJ)

SO DIUM STARCH GLYCO LATE TYPE A CO RN (UNII: AG9 B6 5PV6 B)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

Product Characteristics

Color

white

S core

no sco re

S hap e

OVAL (white bico nvex caplet)

S iz e

Flavor

Imprint Code

GPI;A5

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

NuCare Pharmaceuticals,Inc.

1

NDC:6 8 0 71-4339 -3

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

0 3/16 /20 18

2

NDC:6 8 0 71-4339 -9

9 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 3/16 /20 18

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt343

0 3/27/20 0 6

Labeler -

NuCare Pharmaceuticals,Inc. (010632300)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

NuCare Pharmaceuticals,Inc.

0 10 6 3230 0

re pa c k(6 8 0 71-4339 )

Revised: 5/2019

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