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

PlusPharma Extra Strength by

Drug Labeling and Warnings

PlusPharma Extra Strength by is a Otc medication manufactured, distributed, or labeled by Proficient Rx LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63187-671(NDC:51645-705)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	OVAL (white biconvex caplet)	Size	5mm
Flavor		Imprint Code	GPI;A5
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63187-671-30	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/01/2018
2	NDC: 63187-671-60	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/01/2018
3	NDC: 63187-671-90	90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/01/2018
4	NDC: 63187-671-00	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	03/27/2006

Labeler - Proficient Rx LP (079196022)

Establishment
Name	Address	ID/FEI	Business Operations
Proficient Rx LP		079502574	REPACK(63187-671) , RELABEL(63187-671)