DrugCite

ASPIRIN  - aspirin tablet, delayed release 
Bryant Ranch Prepack

IBU®Tablets

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 E.C 325mg Tablet

Label

ASPIRIN 
aspirin  tablet, delayed release
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 63629-1762 (49483-052)
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPIRIN (ASPIRIN) ASPIRIN 325 mg
Inactive Ingredients
Ingredient Name Strength
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
Color orange Score no score
Shape ROUND Size 10mm
Flavor Imprint Code T
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 63629-1762-1 30  In 1 BOTTLE None
2 63629-1762-2 60  In 1 BOTTLE None
3 63629-1762-3 100  In 1 BOTTLE None
4 63629-1762-4 90  In 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part343 05/08/2022

Labeler - Bryant Ranch Prepack (171714327)
Registrant - Bryant Ranch Prepack (171714327)
Establishment
Name Address ID/FEI Operations
Bryant Ranch Prepack 171714327 REPACK, RELABEL
Revised: 02/2013Bryant Ranch Prepack