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aspirin by REMEDYREPACK INC.

Medically reviewed on January 18, 2018

Dosage form: tablet, chewable
Ingredients: ASPIRIN 81mg
Labeler: REMEDYREPACK INC.
NDC Code: 70518-0699

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.

Major Pharmaceuticals Aspirin 81 mg Drug Facts

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

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 you have ever had an allergic reaction to any other pain reliever/fever reducer
  • for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor

Ask a doctor before use if
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you are taking a diuretic
  • you have 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
  • an allergic reaction occurs. Seek medical help right away.
  • 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
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • ringing in the ears or loss of hearing occurs

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 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. (1-800-222-1222)

Directions
  • 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: consult a doctor

Other information
  • store at 20-25°C (68-77°F)

Inactive ingredients

corn starch, dextrose excipient, FD&C yellow no. 6 aluminum lake, flavors, saccharin sodium

Questions or comments?

1-800-616-2471

DRUG: aspirin

GENERIC: Aspirin

DOSAGE: TABLET, CHEWABLE

ADMINSTRATION: ORAL

NDC: 70518-0699-0

NDC: 70518-0699-1

COLOR: orange

FLAVOR: ORANGE

SHAPE: ROUND

SCORE: No score

SIZE: 8 mm

IMPRINT: L467

PACKAGING: 30 in 1 BOTTLE, PLASTIC

PACKAGING: 36 in 1 BOTTLE

ACTIVE INGREDIENT(S):

  • ASPIRIN 81mg in 1

INACTIVE INGREDIENT(S):

  • FD&C YELLOW NO. 6
  • SACCHARIN SODIUM
  • STARCH, CORN

ASPIRIN 
aspirin tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-0699(NDC:0904-4040)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 6 
SACCHARIN SODIUM 
STARCH, CORN 
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize8mm
FlavorORANGEImprint CodeL467
Contains    
Packaging
#Item CodePackage Description
1NDC:70518-0699-030 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC
2NDC:70518-0699-136 TABLET, CHEWABLE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34308/18/2017
Labeler - REMEDYREPACK INC. (829572556)

 
REMEDYREPACK INC.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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