Drug Labeling and Warnings

Drug Details [pdf]

ASPIRIN- aspirin tablet, coated 
Preferred Pharmaceuticals, 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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Active Ingredient in Each tablet

Aspirin 81 mg (NSAID) Non-steroidal anti-inflammatory drug

In each tablets Aspirin 81 mg (NSAID*)

PAIN RELIEVER

INDICATIONS AND USAGE:

Pain Reliever – temporarily relieves minor aches and pains.  For other uses, see your doctor. Do not use for more than 10 days without consulting your doctor because serious side effects may occur.

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: 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.

DOSAGE AND ADMINISTRATION:

Drink a full glass of water with each dose.  Adults and children 12 years and over; take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor.  Children under 12 years; consult a doctor.

acetylated monoglycerides, anhydrous lactose, colloidal silicon dioxice, croscarmellose sodium, D-CYellow no.10 aluminum lake, hypromellose, hypromellose phthalate, iron oxide yellow (iron oxide ochre), microcrystalline cellulose, mineral oil, polyethylene glycol (PEG) 80, titantium dioxide

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

How Supplied

Bottle of 120 - 68788-0186-2

Relabeled by Preferred Pharmaceuticals, Inc

Anaheim, CA 92870

X:\i4i\Label Scans\Asprin 81mg Delayed Release Enteric Coated, Time cap. 03062017
ASPIRIN 
aspirin tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 68788-0186(NDC: 49483-054)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
aspirin (UNII: R16CO5Y76E) (aspirin - UNII:R16CO5Y76E) aspirin81 mg
Inactive Ingredients
Ingredient NameStrength
anhydrous lactose (UNII: 3SY5LH9PMK)  
carnauba wax (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
croscarmellose sodium (UNII: M28OL1HH48)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
IRON (UNII: E1UOL152H7)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
triethyl citrate (UNII: 8Z96QXD6UM)  
Product Characteristics
ColorYELLOWScoreno score
ShapeROUNDSize7mm
FlavorImprint Code 8
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 68788-0186-2120 in 1 BOTTLE; Type 0: Not a Combination Product06/28/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34306/28/201006/03/2019
Labeler - Preferred Pharmaceuticals, Inc (791119022)
Registrant - Preferred Pharmaceuticals, Inc (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals, Inc791119022REPACK(68788-0186)

Revised: 6/2019