ASPIRIN - aspirin tablet, delayed release 
Bryant Ranch Prepack

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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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

HOW SUPPLIED

Product: 63629-1762

Aspirin E.C 325mg Tablet

Label Image
ASPIRIN 
aspirin tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63629-1762(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:63629-1762-490 in 1 BOTTLE; Type 0: Not a Combination Product05/08/201205/01/2013
2NDC:63629-1762-260 in 1 BOTTLE; Type 0: Not a Combination Product05/08/201205/01/2013
3NDC:63629-1762-7120 in 1 BOTTLE; Type 0: Not a Combination Product05/08/201205/01/2013
4NDC:63629-1762-3100 in 1 BOTTLE; Type 0: Not a Combination Product05/08/201205/01/2013
5NDC:63629-1762-520 in 1 BOTTLE; Type 0: Not a Combination Product05/08/201205/01/2013
6NDC:63629-1762-645 in 1 BOTTLE; Type 0: Not a Combination Product05/08/201205/01/2013
7NDC:63629-1762-130 in 1 BOTTLE; Type 0: Not a Combination Product05/08/201205/01/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34305/08/201205/01/2013
Labeler - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIBusiness Operations
Bryant Ranch Prepack171714327REPACK(63629-1762) , RELABEL(63629-1762)

Revised: 12/2017
 
Bryant Ranch Prepack