Aspirin by REMEDYREPACK INC. Major 44-600A

Aspirin by

Drug Labeling and Warnings

Aspirin by is a Otc medication manufactured, distributed, or labeled by REMEDYREPACK INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ASPIRIN LOW DOSE- aspirin tablet, delayed release 
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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Major 44-600A

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 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.

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

  • take more or for a longer time than directed
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • 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
  • are age 60 or older

Do not use

  • if you are allergic to aspirin 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 asthma
  • 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

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
  • new symptoms occur
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present

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 aspirin at 20 weeks or later in 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

  • do not take more than directed
  • 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: do not use unless directed by a doctor

Other information

  • use by expiration date on package
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

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

Questions or comments?

(800) 616-2471

DRUG: AspirinLow Dose Low Dose

GENERIC: Aspirin

DOSAGE: TABLET, DELAYED RELEASE

ADMINSTRATION: ORAL

NDC: 70518-2668-0

NDC: 70518-2668-1

COLOR: yellow

SHAPE: ROUND

SCORE: No score

SIZE: 6 mm

IMPRINT: L

PACKAGING: 28 in 1 BLISTER PACK

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • ASPIRIN 81mg in 1

INACTIVE INGREDIENT(S):

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

MM2

ASPIRIN  LOW DOSE
aspirin tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70518-2668(NDC: 0904-6751)
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: 70518-2668-028 in 1 BLISTER PACK; Type 0: Not a Combination Product04/03/202012/17/2020
2NDC: 70518-2668-130 in 1 BLISTER PACK; Type 0: Not a Combination Product04/24/202010/13/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/03/202010/13/2023
Labeler - REMEDYREPACK INC. (829572556)

Revised: 10/2023
 

Trademark Results [Aspirin]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ASPIRIN
ASPIRIN
76481358 2788617 Dead/Cancelled
Simon Carter Accessories, Ltd.
2003-01-10
ASPIRIN
ASPIRIN
75209895 not registered Dead/Abandoned
Bayer Aktiengesellschaft
1996-12-09
ASPIRIN
ASPIRIN
73234351 1171777 Dead/Cancelled
McIntyre; William A.
1979-10-09

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