LOW DOSE ASPIRIN ENTERIC SAFETY COATED- aspirin tablet, delayed release 
Time-Cap Labs, Inc

Disclaimer: 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.

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328R ASPIRIN LOW DOSE

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID*)................................Pain reliever

*nonsteroidal anti-inflammatory drug

ANHYDROUS LACTOSE, CARNAUBA WAX, COLLOIDAL SILICON DIOXIDE, CROSCARMELLOSE SODIUM, FD&C YELLOW#6 ALUMINUM LAKE, FD&C RED #40 ALUMINUM LAKE, IRON OXIDE OCHRE, METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER, MICROCRYSTALLINE CELLULOSE, POLYSORBATE 80, SIMETHICONE, SODIUM HYDROXIDE, SODIUM LAURYL SULFATE, TALC, TRIETHYL CITRATE

PURPOSE: PAIN RELIEVER

Uses

  • temporarily relieves minor aches and pains
  • for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur

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
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)

Do not use

  • if you are allergic 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
  • you have not been drinking fluids
  • you have lost a lot of fluid due to vomiting or diarrhea

Ask a doctor or pharmacist before use if you are

Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding:
    • feel faint
    • have bloody or black stools
    • vomit blood
    • 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
  • 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: 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: consult a doctor

IMAGE OF BOTTLE LABEL
LOW DOSE ASPIRIN  ENTERIC SAFETY COATED
aspirin tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-328
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TALC (UNII: 7SEV7J4R1U)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Product Characteristics
Colorwhite (ENTERIC COATED PEACH) Scoreno score
ShapeROUNDSize7mm
FlavorImprint Code emobssed;upper;heart;lower;plain
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49483-328-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/17/2018
2NDC:49483-328-101000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/17/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34308/11/2010
Labeler - Time-Cap Labs, Inc (037052099)
Establishment
NameAddressID/FEIBusiness Operations
Time-Cap Labs, Inc037052099manufacture(49483-328)

Revised: 12/2018
Document Id: 7d3b6a67-60c8-162a-e053-2991aa0a7164
Set id: 55d645bb-8645-4984-a7b9-3e6eed8c6412
Version: 2
Effective Time: 20181217
 
Time-Cap Labs, Inc