Your browser does not support JavaScript! ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [RUGBY LABORATORIES, INC]
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ENTERIC COATED ASPIRIN (aspirin) tablet, delayed release
[Rugby Laboratories, Inc]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0536-3313
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
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
ColororangeScoreno score
ShapeROUNDSize11mm
FlavorImprint Code T
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-3313-01100 in 1 BOTTLE
2NDC:0536-3313-101000 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34309/20/2011
Labeler - Rugby Laboratories, Inc (109178264)
Registrant - Time Cap Labs, Inc (037052099)
Establishment
NameAddressID/FEIBusiness Operations
Time Cap Labs, Inc037052099manufacture

Revised: 9/2011
 
Rugby Laboratories, Inc

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