ASPIRIN ENTERIC COATED- aspirin 81 mg tablet

ASPIRIN by

Drug Labeling and Warnings

ASPIRIN by is a Otc medication manufactured, distributed, or labeled by Allegiant Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Aspirin 81mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

for the temporary relief of minor aches and pain or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.

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 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 non presecription 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 are allergic to aspirin or 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
• anticoagulation (thinning of the blood)
• diabetes
• gout
• arthritis
  

Stop use and ask a doctor if

• an 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
• new symptoms occur
• ringing in the ears or loss of hearing occurs
• You may report serious side effects to 1-888-952-0050
  

Pregnancy/Breastfeeding

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 specifically 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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

• drink a full glass of water with each dose  
• adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor 
• children under 12 years of age: consult a doctor

Other information

• save carton for full directions and warnings
• store at room temperature
• do not use if imprinted safety seal under cap is broken or missing
  

Inactive ingredients

anhydrous lactose, carnauba wax, croscarmellose sodium, D&C yellow #10 aluminum lake, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, silicon dioxide, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

Principal Display Panel

Bio Formula

ASPIRIN

(NSAID*)

81mg SAFETY COATED

ENTERIC COATED

LOW STRENGTH ASPIRIN REGIMEN

DELAYED RELEASE ASPIRIN

Bio Formula Aspirin 81mg Carton 100ct

Bio Formula Aspirin 81mg Label 100ct

Bio Formula Aspirin 81mg Label 300ct

INGREDIENTS AND APPEARANCE

ASPIRIN  ENTERIC COATED
aspirin 81 mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69168-318
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
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
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)
METHACRYLIC ACID (UNII: 1CS02G8656)

Product Characteristics
Color	YELLOW	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	A
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69168-318-01	1 in 1 CARTON	12/18/2014
1		100 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 69168-318-03	300 in 1 BOTTLE; Type 0: Not a Combination Product	12/18/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part343	12/18/2014

Labeler - Allegiant Health (079501930)

Registrant - Allegiant Health (079501930)