ASPIRIN- aspirin tablet, delayed release 
TIME CAP LABORATORIES 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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131r obsolete

Each tablet contains - Aspirin 325 mg (NSAID)

Keep Out of the Reach of Children:   In case of overdose, get medical help or contact a Poison Control Center right away

PAIN RELIEVER

For the temporary relief of minor aches and pains due to: muscle pain, toothache, headache, colds, menstrual pain, minor pain of arthritis or as directed by your physician

Drink a full glass of water with each dose.   Adults and children 12 years and over; take 1 to 2 tablets every 4 hours while symptoms last.   Do not take more than 12 tablets in 24 hours unless directed by a doctor.   Children under 12 years; consult a doctor.

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: facial swelling, shock, hives, 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, take other drugs containing prescription or nonprescription NSAIDS(aspirin, ibuprofen, naproxen or others), have 3 or more alcoholic drinks every day while using this product, take more or for a longer time than directed.

acetylated monoglycerides

corn starch

croscarmellose sodium

D-C yellow #10

FD-C yellow #6

Hypromellose

Hypromellose phthalate

microcrystalline cellulose

mineral oil

polyethylene glycol (PEG) 400

polysorbate 80

titanium dioxide

131LABEL
ASPIRIN 
aspirin tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-052
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
DIACETYLATED MONOGLYCERIDES (UNII: 5Z17386USF)  
STARCH, CORN (UNII: O8232NY3SJ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST) (UNII: G4U024CQK6)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize10mm
FlavorImprint Code T
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49483-052-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/08/201201/01/2018
2NDC:49483-052-101000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/08/201201/01/2018
3NDC:49483-052-00100000 in 1 CARTON; Type 0: Not a Combination Product05/08/201201/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34305/08/201201/01/2018
Labeler - TIME CAP LABORATORIES INC. (037052099)
Establishment
NameAddressID/FEIBusiness Operations
TIME CAP LABORATORIES, INC.037052099manufacture(49483-052)

Revised: 12/2018
 
TIME CAP LABORATORIES INC.