PLUS PHARMA NSAID ASPIRIN- aspirin tablet

Plus Pharma NSAID Aspirin by

Drug Labeling and Warnings

Plus Pharma NSAID Aspirin by is a Otc medication manufactured, distributed, or labeled by St. Mary's Medical Park Pharmacy, Gemini Pharmaceuticals, Inc. dba Plus Pharma. 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

Reye's syndrome: 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.

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

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

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

• 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

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 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

definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

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
• Adults and children 12 years and older: 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
  
• Children under 12: ask a doctor

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.

Principal Display Panel

INGREDIENTS AND APPEARANCE

PLUS PHARMA NSAID ASPIRIN 
aspirin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60760-718(NDC: 51645-716)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	325 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
POVIDONE (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: 60760-718-24	24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/14/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part343	03/27/2006

Labeler - St. Mary's Medical Park Pharmacy (063050751)

Registrant - Gemini Pharmaceuticals, Inc. dba Plus Pharma (055942270)

Establishment
Name	Address	ID/FEI	Business Operations
St. Mary's Medical Park Pharmacy		063050751	repack(60760-718) , relabel(60760-718)