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ASPIRIN by TIME CAP LABORATORIES INC.

Medically reviewed on May 8, 2018

Dosage form: tablet, delayed release
Ingredients: ASPIRIN 325mg
Labeler: TIME CAP LABORATORIES INC.
NDC Code: 49483-052

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.

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.

acetylted 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

ASPIRIN 
aspirin tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-052
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
DIACETYLATED MONOGLYCERIDES 
STARCH, CORN 
CROSCARMELLOSE SODIUM 
D&C YELLOW NO. 10 
FD&C YELLOW NO. 6 
HYPROMELLOSES 
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST) 
CELLULOSE, MICROCRYSTALLINE 
MINERAL OIL 
POLYETHYLENE GLYCOL 400 
POLYSORBATE 80 
TITANIUM DIOXIDE 
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize10mm
FlavorImprint CodeT
Contains    
Packaging
#Item CodePackage Description
1NDC:49483-052-01100 TABLET, DELAYED RELEASE (TABLET) in 1 BOTTLE, PLASTIC
2NDC:49483-052-101000 TABLET, DELAYED RELEASE (TABLET) in 1 BOTTLE, PLASTIC
3NDC:49483-052-00100000 TABLET, DELAYED RELEASE (TABLET) in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34305/08/2012
Labeler - TIME CAP LABORATORIES INC. (037052099)
Establishment
NameAddressID/FEIOperations
TIME CAP LABORATORIES, INC.037052099manufacture

 
TIME CAP LABORATORIES INC.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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