LOW DOSE ASPIRIN- aspirin tablet, coated 
TIME CAP LABORATORIES, INC

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481R TCL 49483-481 ASPIRIN 81MG DELAYED RELEASE TABLETS

DRUG FACTS

Active ingredient (in each tablet)
Aspirin 81 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Purpose
Pain reliever

Uses
for the temporary relief of minor aches and pains 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.
ask your doctor about other uses for enteric-coated 81 mg Aspirin

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:

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

Do not use

Ask a doctor before use if

Ask a doctor or pharmacist before use if you are taking a prescription drug for: ­

Stop use and ask a doctor if

feel faint

vomit blood

have bloody or black stools

have stomach pain that does not get better

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 (1-800-222-1222) right away.

Directions

OTHER INFORMATION

Other information

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

Questions or comments?Call 1-877-290-4008

481r-timely-120saspirin-timely-label481R-timely-365ct-label481R-timely-1000-label300

LOW DOSE ASPIRIN 
aspirin tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-481
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
BROWN IRON OXIDE (UNII: 1N032N7MFO)  
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize7mm
FlavorImprint Code HEART
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49483-481-101000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/19/2015
2NDC:49483-481-12120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/19/2015
3NDC:49483-481-001000000 in 1 CARTON; Type 0: Not a Combination Product06/19/2015
4NDC:49483-481-31300 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/03/2021
5NDC:49483-481-50500 in 1 BOTTLE; Type 0: Not a Combination Product06/24/2021
6NDC:49483-481-65365 in 1 BOTTLE; Type 0: Not a Combination Product07/30/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01306/19/2015
Labeler - TIME CAP LABORATORIES, INC (037052099)
Registrant - TIME CAP LABORATORIES, INC (037052099)
Establishment
NameAddressID/FEIBusiness Operations
TIME CAP LABORATORIES, INC037052099manufacture(49483-481)

Revised: 12/2023
Document Id: 0db42a3e-0e86-1b7c-e063-6294a90a59f5
Set id: 1acc8c1a-c746-4635-800c-de1ad758fce0
Version: 9
Effective Time: 20231230
 
TIME CAP LABORATORIES, INC