Aspirin by ILEX Consumer Products Group, LLC (ST. JOSEPH) ASPIRIN tablet, coated

Aspirin by

Drug Labeling and Warnings

Aspirin by is a Otc medication manufactured, distributed, or labeled by ILEX Consumer Products Group, LLC (ST. JOSEPH). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

• temporarily relieves minor aches and pains due to:
  • headache
  • menstrual pain
  • minor arthritis pain
  • muscle pain
  • toothache
  • colds
• or as recommended by a doctor

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
• shock
• asthma (wheezing)

Stomach bleeding warning: This product contains an 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

if you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer.

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
• you have asthma

Ask a doctor or pharmacist before use if you are

taking a prescription drug for diabetes, gout, or arthritis.

Stop use and ask a doctor if

• allergic reaction occurs. Seek medical help right away.
• 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
• redness or swelling is present
• any new symptoms appear
• ringing in the ears or loss of hearing occurs. These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use aspirin during the 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.

Keep out of reach of children.

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

Directions

• adults and children 12 years of age or over: take 1 to 2 tablets every 4 hours, while symptoms persist. Drink a full glass of water with each dose.
• do not take more than 12 tablets in 24 hours unless directed by a doctor
• children under 12 years of age: ask a doctor

Other information

• store at controlled room temperature 15°-30°C (59°-86°F)
• do not use if imprinted safety seal under cap is broken or missing

Inactive ingredients

corn starch, croscarmellose sodium, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, mineral oil, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

Questions or comments?

call toll free: 1 855 STJOE81

Principal Display Panel

Regular Strength

SAFETY COATED* ASPIRIN

PAIN RELIEVER (NSAID)

325 mg

ASPIRIN REGIMEN

enteric coated TABLETS 325mg each

*Coating Helps Protect Against Stomach Upset

Talk to your doctor before starting an aspirin regimen. Aspirin is not right for everyone.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Dist. by: St. Josephs Health Products, LLC

Baltimore, MD 21201

Package Label

St. Joseph Aspirin 325 mg Tablet

 

INGREDIENTS AND APPEARANCE

ASPIRIN 
aspirin tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76000-370
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)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSES (UNII: 3NXW29V3WO)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

Product Characteristics
Color	ORANGE	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	T
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76000-370-12	1 in 1 BOX
1		125 in 1 BOTTLE, PLASTIC
2	NDC: 76000-370-36	1 in 1 BOX
2		365 in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part343	03/15/2012

Labeler - ILEX Consumer Products Group, LLC (ST. JOSEPH) (829056162)