Kem Pharma 44-600A Aspir-81

Kem Pharma 44-600A Aspir-81

Drug Labeling and Warnings

Drug Details

k">

ASPIR-81- acetylsalicylic acid tablet, coated 
KEM Pharma LLC

----------

Kem Pharma 44-600A Aspir-81

Active ingredient (in each tablet)

Acetylsalicylic Acid 81 mg (NSAID)*
*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

As recommended by your doctor. As an antiaggregant in antiplatelet therapy or for temporary relief of minor aches and pains.

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: Acetylsalicylic acid 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

  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • are age 60 or older
  • take more or for a longer time than directed
  • have had stomach ulcers or bleeding problems
  • have 3 or more alcoholic drinks every day while using this product
  • take a blood thinning (anticoagulant) or steroid drug

Do not use

  • if you are allergic to Acetylsalicylic acid or any other pain reliever/fever reducer
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if

  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you are taking a diuretic
  • you have high blood pressure, heart disease, liver cirrhosis or kidney disease
  • you have asthma

Ask a doctor or pharmacist before use if you are

taking a prescription drug for

  • gout
  • diabetes
  • arthritis

Stop use and ask a doctor if

  • an allergic reaction occurs. Seek medical help right away.
  • you experience any of the following signs of stomach bleeding:
    • vomit blood
    • have bloody or black stools
    • feel faint
    • have stomach pain that does not get better
  • ringing in the ears or a loss of hearing occurs
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present
  • new symptoms occur

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use Acetylsalicylic acid 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 right away.

Directions

  • drink a full glass of water with each dose
  • as an antiaggregant in platelet therapy take one tablet daily or as recommended by your doctor
  • children under 12 years: do not use unless directed by a doctor

Other information

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

Inactive ingredients

corn starch, D&C yellow #10, FD&C yellow #6, hypromellose, methacrylic acid, microcrystalline cellulose, polydextrose, polyethylene glycol, shellac wax, silica, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate

Principal display panel

KEM™

KEM PHARMA™

ASPIR-81™

Acetylsalicylic Acid 81 mg

Antiaggregant
Pain Reliever (NSAID)

✓ Antiaggregant
✓ Enteric Coated

Actual Size

2x365
Coated Tablets

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY
SEAL UNDER CAP IS BROKEN OR MISSING

Manufactured by: LNK INTERNATIONAL, INC.
60 Arkay Drive, Hauppauge, NY 11788 USA
For: KEM Pharma LLC
Setauket, NY 11733, USA
(001)(631)297-4498 WWW.Kempharma.com
Authorized Distributor in Mongolia:
Tegsh-Anar Co., Ltd
Tel: 70 13 35 35
This product does not contain GLUTEN

Kem Pharma Aspir-81

Kem Pharma Aspir-81


ASPIR-81 
acetylsalicylic acid tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 60503-601
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
METHACRYLIC ACID (UNII: 1CS02G8656)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SHELLAC (UNII: 46N107B71O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
WATER (UNII: 059QF0KO0R)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Product Characteristics
ColorYELLOWScoreno score
ShapeROUNDSize6mm
FlavorImprint Code L
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 60503-601-962 in 1 CARTON03/04/2019
1365 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
EXPORT ONLY03/04/2019
Labeler - KEM Pharma LLC (079090402)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(60503-601)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(60503-601)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088MANUFACTURE(60503-601) , PACK(60503-601)

Revised: 2/2019
 
KEM Pharma LLC


© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.