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

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.

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Drug Facts

Active ingredient (in each tablet)

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 tablets (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 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

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.

Principal Display Panel

Repackaged by:
Proficient Rx LP
Thousand Oaks, CA 91320

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 Extra Strength Tylenol®

30 TABLETS 500 mg each

63187-293-30
PLUSPHARMA EXTRA STRENGTH  PAIN RELIEVER,FEVER REDUCER 500 MG
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-293(NDC:51645-706)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUND (round flat faced beveled edge) Size12mm
FlavorImprint Code GPI;A5
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63187-293-1010 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/04/2018
2NDC:63187-293-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/2014
3NDC:63187-293-4040 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2017
4NDC:63187-293-5050 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/2017
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/FEIBusiness Operations
Proficient Rx LP079196022REPACK(63187-293) , RELABEL(63187-293)

Revised: 11/2019
Document Id: aa1ff859-2ff4-43e8-be4f-e0f4f369c20a
Set id: 73bff948-3ecd-4700-994f-177c967f9164
Version: 6
Effective Time: 20191101
 
Proficient Rx LP