LOW DOSE ASPIRIN- aspirin tablet, coated 
Proficient Rx LP

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481R-TCL-49483-481 ASPIRIN 81MG DELAYED RELEASE TABLETS

DRUG FACTS

Active ingredient (in each tablet)

Aspirin 81mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Purpose

Pain Reliever

Keep Out of Reach of Children

Keep out of reach of children. In case of overdose get medical help or contact a poison control center right away.

Uses

for the temporary relief of minor aches and pains or as recommended by your doctor Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.
ask your doctor about other uses for enteric-coated 81 mg Aspirin

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:hives, facial swelling, shock, 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 bleeding problems

Take a blood thinning (anticoagulant) or steroid drug

Take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen or others)

Directions

Drink a full glass of water with each dose

Adults and children of 12 years and over, take 4-8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor

Children under 12 years: consult a doctor

Inactive Ingredients

Anhydrous lactose, carnuba wax, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 aluminum lake, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate.

Package/Label Principal Display Panel

71205-112-30
LOW DOSE ASPIRIN 
aspirin tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71205-112(NDC:49483-481)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Product Characteristics
ColorYELLOWScoreno score
ShapeROUNDSize7mm
FlavorImprint Code HEART
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71205-112-1010 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/04/2018
2NDC:71205-112-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/04/2018
3NDC:71205-112-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/04/2018
4NDC:71205-112-72120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01306/19/2015
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIBusiness Operations
Proficient Rx LP079196022REPACK(71205-112) , RELABEL(71205-112)

Revised: 12/2023
Document Id: b5be56e1-4e72-405e-aef7-0cd09d5bf0de
Set id: e839bff7-779a-446d-8486-c0e0a1b6d665
Version: 7
Effective Time: 20231201
 
Proficient Rx LP