ASPIRIN- aspirin tablet, coated 
NuCare 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)*
*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

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:

Stomach bleeding warning:

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

Do not use if your are allergic to aspirin or any other pain reliever/fever reducer.

Ask a doctor before use if

Ask a doctor or pharmacist before use if you are

Stop use and ask a doctor if

These can be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use. it is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children. In case of overdose , get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

cellulose, croscarmellose sodium, D&C Yellow #10 Lake, lactose monohydrate, methacrylic acid co-polymer, PEG, polacrilin potassium, polyvinyl alcohol, silica, sodium lauryl sulfate, soya powder, talc, titanium dioxide, triethyl citrate

Questions or comments?

1-800-540-3765

package label

pdp

ASPIRIN 
aspirin tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68071-2795(NDC:57896-983)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
POLACRILIN POTASSIUM (UNII: 0BZ5A00FQU)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SOYBEAN (UNII: L7HT8F1ZOD)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize6mm
FlavorImprint Code P
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68071-2795-2120 in 1 BOTTLE; Type 0: Not a Combination Product07/19/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34307/01/2021
Labeler - NuCare Pharmaceuticals,Inc. (010632300)
Establishment
NameAddressID/FEIBusiness Operations
NuCare Pharmaceuticals,Inc.010632300relabel(68071-2795)

Revised: 7/2022
Document Id: e42c5abb-492e-d19b-e053-2995a90a7e3e
Set id: e42c611c-2b2e-12b2-e053-2a95a90af00b
Version: 1
Effective Time: 20220719
 
NuCare Pharmaceuticals,Inc.