ADULT LOW DOSE ENTERIC COATED ASPIRIN- aspirin tablet, coated 
REMEDYREPACK INC.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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gc 981

Active ingredient (in each tablet)

Aspirin 81 mg(NSAID)*
*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

  • for the temporary relief of minor aches and pains
  • ask your doctor about other uses for 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
  • asthma (wheezing)
  • shock

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

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

Ask a doctor before use if

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

Ask a doctor or pharmacist before use if you are

  • taking a prescription drug for diabetes, gout or arthritis

Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding: -feel faint -vomit blood -have bloody or black stools -have stomach pain that does not get better
  • an allergic reaction occurs. Seek medical help right away
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present
  • fever gets worse or lasts more than 3 days
  • any new symptoms occur
  • ringing in the ears or loss of hearing occurs

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

  • drink a full glass of water with each dose
  • swallow whole, do not chew or crush
  • do not exceed recommended dose
  • adults and children 12 years and older: take 4-8 tablets every 4 hours, as needed, not more than 48 tablets in 24 hours, or as directed by a doctor
  • children under 12 years: ask a doctor

Other information

  • store at 20-25°C (68-77°F); excursions permitted between 15°C - 30°C (59°F - 86°F)

Inactive ingredients

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

Questions or comments?

1-800-540-3765

DRUG: Adult Low Dose Enteric Coated Aspirin

GENERIC: Aspirin

DOSAGE: TABLET, COATED

ADMINSTRATION: ORAL

NDC: 70518-0928-0

NDC: 70518-0928-1

NDC: 70518-0928-2

NDC: 70518-0928-3

NDC: 70518-0928-4

NDC: 70518-0928-5

NDC: 70518-0928-6

NDC: 70518-0928-7

NDC: 70518-0928-8

COLOR: yellow

SHAPE: ROUND

SCORE: No score

SIZE: 6 mm

IMPRINT: L

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 28 in 1 BLISTER PACK

PACKAGING: 90 in 1 BOTTLE PLASTIC

PACKAGING: 100 in 1 BOX

PACKAGING; 1 in 1 POUCH

PACKAGING: 90 in 1 BOTTLE PLASTIC

PACKAGING: 10 in 1 BOTTLE PLASTIC

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 28 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • ASPIRIN 81mg in 1

INACTIVE INGREDIENT(S):

  • TRIETHYL CITRATE
  • CELLULOSE, MICROCRYSTALLINE
  • METHACRYLIC ACID
  • HYPROMELLOSES
  • FD&C YELLOW NO. 6
  • D&C YELLOW NO. 10
  • STARCH, CORN
  • POLYDEXTROSE
  • SHELLAC
  • TITANIUM DIOXIDE
  • TALC
  • SODIUM LAURYL SULFATE
  • SODIUM BICARBONATE
  • DIMETHICONE
  • SILICON DIOXIDE
  • TRIACETIN
  • POLYETHYLENE GLYCOL, UNSPECIFIED

Remedy_Label

ADULT LOW DOSE ENTERIC COATED ASPIRIN 
aspirin tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-0928(NDC:57896-981)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
SHELLAC (UNII: 46N107B71O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
STARCH, CORN (UNII: O8232NY3SJ)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
METHACRYLIC ACID (UNII: 1CS02G8656)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize6mm
FlavorImprint Code L
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70518-0928-030 in 1 BLISTER PACK; Type 0: Not a Combination Product01/04/201809/09/2021
2NDC:70518-0928-128 in 1 BLISTER PACK; Type 0: Not a Combination Product09/17/201807/24/2020
3NDC:70518-0928-290 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/29/201908/30/2019
4NDC:70518-0928-3100 in 1 BOX11/04/201911/04/2019
4NDC:70518-0928-41 in 1 POUCH; Type 0: Not a Combination Product
5NDC:70518-0928-590 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/15/202010/12/2023
6NDC:70518-0928-610 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/31/202007/31/2020
7NDC:70518-0928-730 in 1 BLISTER PACK; Type 0: Not a Combination Product11/16/202007/12/2021
8NDC:70518-0928-828 in 1 BLISTER PACK; Type 0: Not a Combination Product11/17/202011/18/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/04/201810/12/2023
Labeler - REMEDYREPACK INC. (829572556)

Revised: 10/2023
 
REMEDYREPACK INC.