Skip to Content

← See all PlusPharma Extra Strength PAIN RELIEVER,FEVER REDUCER 500 mg brands

PlusPharma Extra Strength PAIN RELIEVER,FEVER REDUCER 500 mg

Medically reviewed on March 1, 2018

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg
Labeler: Proficient Rx LP
NDC Code: 63187-671

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

Purposes

Pain reliever/fever reducer

Uses
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
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 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.

Questions?

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

Repackaged by:

Proficient Rx LP

Thousand Oaks, CA 91320

Principal Display Panel

PlusPHARMA

See New Warnings Information and Directions

Extra Strength

ACETAMINOPHEN 500 mg

PAIN RELIEVER  FEVER REDUCER

CONTAINS NO ASPIRIN

Compare to the Active Ingredient in Extra Strength Tylenol®

This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol®

100 CAPLETS 500 mg each

PlusPHARMA

See New Warnings Information and Directions

Extra Strength

ACETAMINOPHEN 500 mg

PAIN RELIEVER  FEVER REDUCER

CONTAINS NO ASPIRIN

Compare to the Active Ingredient in Extra Strength Tylenol®

This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol®

60 CAPLETS 500 mg each

PlusPHARMA

See New Warnings Information and Directions

Extra Strength

ACETAMINOPHEN 500 mg

PAIN RELIEVER  FEVER REDUCER

CONTAINS NO ASPIRIN

Compare to the Active ingredient in Extra Strength Tylenol®

This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol®

1000 CAPLETS 500 mg each

PLUSPHARMA EXTRA STRENGTH  PAIN RELIEVER,FEVER REDUCER 500 MG
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-671(NDC:51645-705)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONES 
STARCH, CORN 
SODIUM STARCH GLYCOLATE TYPE A CORN 
STEARIC ACID 
Product Characteristics
ColorwhiteScoreno score
ShapeOVAL (white biconvex caplet) Size5mm
FlavorImprint CodeGPI;A5
Contains    
Packaging
#Item CodePackage Description
1NDC:63187-671-3030 TABLET in 1 BOTTLE, PLASTIC
2NDC:63187-671-6060 TABLET in 1 BOTTLE, PLASTIC
3NDC:63187-671-9090 TABLET in 1 BOTTLE, PLASTIC
4NDC:63187-671-00100 TABLET in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34303/27/2006
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIOperations
Proficient Rx LP079502574REPACK(63187-671), RELABEL(63187-671)

 
Proficient Rx LP

← See all PlusPharma Extra Strength PAIN RELIEVER,FEVER REDUCER 500 mg brands

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide