ENTERIC COATED ASPIRIN REGULAR STRENGTH- 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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331R Timely 49483-331 Aspirin 325mg Delayed Release Tablets

DRUG FACTS

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

Purpose
Pain reliever

Uses
temporarily relieves minor aches and pains due to:

or as recommended by a doctor

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

Stop use and ask a doctor if

feel faint
have bloody or black stools
vomit blood
have stomach pain that does not get better

These could be signs of a serious condition.

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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Other information

Inactive ingredients corn starch, croscarmellose sodium, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, mineral oil, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

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

331R-Timely-Aspirin-bottle label-1000sbulk label update

ENTERIC COATED ASPIRIN  REGULAR STRENGTH
aspirin tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-331
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg  in 325 
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize11mm
FlavorImprint Code T
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49483-331-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/10/2011
2NDC:49483-331-00100000 in 1 CARTON; Type 0: Not a Combination Product04/10/2011
3NDC:49483-331-101000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/10/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34301/04/2011
Labeler - Time-Cap Labs, Inc (037052099)
Registrant - Time-Cap Labs, Inc (037052099)
Establishment
NameAddressID/FEIBusiness Operations
Time-Cap Labs, Inc037052099manufacture(49483-331)

Revised: 1/2022
Document Id: cd865e39-baff-da9b-e053-2995a90a9547
Set id: 5fbd8bb3-46f9-4089-9a21-b6af97a06106
Version: 7
Effective Time: 20220124
 
Time-Cap Labs, Inc