DrugCite

ENTERIC COATED ASPIRIN  - aspirin tablet, delayed release 
Rugby Laboratories, Inc

DRUG FACTS

Active ingredient (in each tablet)
Aspirin 325 mg (NSAID*)
*nonsteroidal anti-inflammatory drug

Purpose
Pain reliever

Uses
temporarily relieves
  • headache
  • muscle pain
  • menstrual pain
  • toothache
  • minor pain of arthritis
  • pain and fever of colds

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
  • shock
  • facial swelling
  • asthma (wheezing)
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if the user
  • has had stomach ulcers or bleeding problems
  • takes a blood thinning (anticoagulant) or steroid drug
  • takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • takes more or for a longer time than directed
  • has 3 or more alcoholic drinks every day while using this product
  • is age 60 or older

Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer

Ask a doctor before use if
  • stomach bleeding warning applies to user
  • user has a history of stomach problems such as heartburn
  • user has high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • user is taking a diuretic
  • user has asthma
  • user has not been drinking fluids

Ask a doctor or pharmacist before use if user is
  • taking a prescription drug for diabetes, gout, or arthritis
  • taking any other drug
  • under a doctor's care for any serious condition

Stop use and ask a doctor if
  • user experiences any of the following signs of stomach bleeding:
    • feels faint
    • vomits blood
    • has bloody or black stools
    • has 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
  • redness or swelling is present in the painful area
  • any new symptoms appear
  • ringing in the ears or a loss of hearing occurs

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
DRINK A FULL GLASS OF WATER WITH EACH DOSE
  • adults and children 12 years and over: 1 - 2 tablets every 4 hours while symptoms last, not more than 12 tablets in 24 hours
  • children under 12 years: ask a doctor

Other information
  • store at 20° - 25°C (68° - 77°F)

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 1-800-645-2158, 9 am - 5 pm ET, Monday - Friday

BOTTLE LABEL


ENTERIC COATED ASPIRIN 
aspirin  tablet, delayed release
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 0536-3313
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPIRIN (ASPIRIN) ASPIRIN 325 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN  
CROSCARMELLOSE SODIUM  
D&C YELLOW NO. 10  
FD&C YELLOW NO. 6  
HYPROMELLOSE 2910 (6 MPA.S)  
HYPROMELLOSE 2910 (15 MPA.S)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A  
CELLULOSE, MICROCRYSTALLINE  
MINERAL OIL  
POLYSORBATE 80  
SILICON DIOXIDE  
DIMETHICONE  
SODIUM HYDROXIDE  
SODIUM LAURYL SULFATE  
TALC  
TITANIUM DIOXIDE  
TRIETHYL CITRATE  
Product Characteristics
Color orange Score no score
Shape ROUND Size 11mm
Flavor Imprint Code T
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 0536-3313-01 100 TABLET In 1 BOTTLE None
2 0536-3313-10 1000 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part343 09/20/2011

Labeler - Rugby Laboratories, Inc (109178264)
Registrant - Time Cap Labs, Inc (037052099)
Establishment
Name Address ID/FEI Operations
Time Cap Labs, Inc 037052099 manufacture
Revised: 09/2011Rugby Laboratories, Inc