PLUS PHARMA PAIN RELIEVER,FEVER REDUCER- acetaminophen tablet

Plus Pharma by

Drug Labeling and Warnings

Plus Pharma 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 tablet)

Acetaminophen 325 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. Severe liver damage may occur if

• adult takes more than 12 tablets in 24 hours, which is the maximum daily amount
• child takes more than 5 doses in 24 hours
  
• taken with other drugs containing acetaminophen 
• adult has 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 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 the user has

liver disease.

Ask a doctor or pharmacist before use if the user is

taking the blood thinning drug warfarin.

Stop use and ask a doctor if

• Pain gets worse or lasts more than 10 days in adults and children
  
• Pain gets worse or lasts more than 5 days in children under 12 years
  
• 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 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

• AGE:

  DOSE

• Adults and Children 12 years and over:
  • Take 2 tablets every 4 to 6 hours while symptoms last
  • Do not take more than 12 tablets in 24 hours
• Children 6 - 11 years:
  • Take 1 tablet every 4 to 6 hours while symptoms last
  • Do not take more than 5 tablets in 24 hours
• Children under 6 years:

  Do not use adult Regular Strength products in children under 6 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.;

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

See New Warnings Information

NDC: 63187-528-00

PlusPHARMA

Repackaged By:

Proficient Rx LP

Thousand Oaks, CA 91320

Regular Strength

ACETAMINOPHEN

325 mg

PAIN RELIEVER  FEVER REDUCER

CONTAINS NO ASPIRIN

Compare to the Active Ingredient in Regular Strength Tylenol®

*Plus Pharma is not affiliated with the owner of the registered trademark Tylenol®.

100 TABLETS  325 mg each

INGREDIENTS AND APPEARANCE

PLUS PHARMA  PAIN RELIEVER,FEVER REDUCER
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63187-528(NDC:51645-703)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Inactive Ingredients
Ingredient Name	Strength
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white (round)	Score	no score
Shape	ROUND (flat faced beveled edge)	Size	10mm
Flavor		Imprint Code	GPI;A325
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63187-528-20	20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2018
2	NDC: 63187-528-30	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2018
3	NDC: 63187-528-60	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2018
4	NDC: 63187-528-90	90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2018
5	NDC: 63187-528-00	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2018

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		079196022	REPACK(63187-528) , RELABEL(63187-528)