PLUS PHARMA NSAID 325 MG- aspirin tablet

Plus Pharma by

Drug Labeling and Warnings

Plus Pharma by is a Otc medication manufactured, distributed, or labeled by TYA Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Aspirin 325 mg (NSAID)*

* nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Uses

for temporary relief of

• headache
• muscular aches
• backache
• minor pain of arthritis
• the common cold
• toothache
• menstrual cramps
• minor aches and pains
• temporarily reduces fever

Warnings

Children and teenagers who have or are recovering from chicken pox or flu- like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Reye's syndrome:

Aspirin may cause a severe allergic reaction, which may include Allergy alert:

• hives
  
• facial swelling
• asthma(wheezing)
• shock

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you Stomach bleeding warning:

• are age 60 or older
• have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
• have 3 or more alcoholic drinks every day while using this product
• take more or for a longer time than directed

Do not use

with any other product containing Aspirin or if you have ever had an allergic reaction to aspirin or other pain relievers/fever reducers.

Ask a doctor before use if

• stomach bleeding warning applies to you
• you have a history of stomach problems, such as heartburn
• you have high blood pressure, heart disease, liver cirrhosis or kidney disease
• you are taking a diuretic

Ask a doctor or pharmacist before use if you are

taking a prescription drug for

• anticoagulation (blood thinning)
• gout
• diabetes
• arthritis

Stop use and ask a doctor if

• you experience any of the following signs of stomach bleeding
• feel faint
  
• vomit blood
  
• have  bloody or black stools
• have stomach pain that does not get better
• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• new symptoms occur
• ringing in the ears or hearing loss occurs
• redness or swelling is present
  

, ask a health professional before use. It is especially important not to use Aspirin during last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. If pregnant or breast-feeding

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• Drink a full glass of water with each dose
• Do not take more than directed
• take 1 to 2 tablets every 4 hours, or 3 tablets every 6 hours as needed. Do not take more than 12 tablets in 24 hours Adults and children 12 years and older:
  
• ask a doctor Children under 12:

Other information

• Do not use if imprinted safety seal under cap is broken or missing.
• Store at room temperature
  

Inactive ingredients

Corn Starch, Povidone.

Questions?

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

PLUS PHARMA NSAID 325 MG (ASPIRIN) TABLET

INGREDIENTS AND APPEARANCE

PLUS PHARMA   NSAID 325 MG
aspirin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64725-0716(NDC: 51645-716)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	81 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
POVIDONES (UNII: FZ989GH94E)

Product Characteristics
Color	white	Score	no score
Shape	ROUND (bi-convex tablet)	Size	10mm
Flavor		Imprint Code	Aspirin;GPI
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64725-0716-1	100 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part343	09/29/2014

Labeler - TYA Pharmaceuticals (938389038)

Registrant - TYA Pharmaceuticals (938389038)

Establishment
Name	Address	ID/FEI	Business Operations
TYA Pharmaceuticals		938389038	RELABEL(64725-0716) , REPACK(64725-0716)