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ASPIRIN by REMEDYREPACK INC.

Medically reviewed on December 1, 2016

Dosage form: tablet, coated
Ingredients: ASPIRIN 325mg
Labeler: REMEDYREPACK INC.
NDC Code: 70518-0030

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.

ACTIVE INGREDIENTS


Each tablet contains Aspirin 325 mg (NSAID)

INACTIVE INGREDIENTS

Corn Starch, Croscramellose Sodium, Hypromellose, Microcrystalline Cellulose, Mineral Oil, Titanium Dioxide

PURPOSE

Pain Reliever

DOSAGE AND ADMINISTRATION

Drink a full glass of water with each doses

Adults and children 12 years and over: TAKE 1 TO 2 TABLETS EVERY 4 HOURS WHILE SYMPTOMS  LAST.  DO NOT TAKE MORE THAN 12 TABLETS IN 24 HOURS, UNLESS DIRECTED BY A DOCTOR.

Children under 12 years: CONSULT A DOCTOR.

INDICATIONS AND USAGE

For the temporary relief of aches and pains due to:

headache, colds,menstral pain, muscle pain, toothache,minor pain of arthritis or as directed by your doctor

WARNINGS

Reyes'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 reactin, which may include hives, facial swelling, shock, asthma (wheezing)

Stomach bleeding warning:  This produc tcontains 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 non prescription 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.

KEEP OUT OF THE REACH OF CHILDREN

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

DRUG: ASPIRIN

GENERIC: ASPIRIN

DOSAGE: TABLET, COATED

ADMINSTRATION: ORAL

NDC: 70518-0030-0

COLOR: white

SHAPE: ROUND

SCORE: No score

SIZE: 10 mm

IMPRINT: TCL011

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • ASPIRIN 325mg in 1

INACTIVE INGREDIENT(S):

  • CELLULOSE, MICROCRYSTALLINE
  • HYPROMELLOSES
  • MINERAL OIL
  • CROSCARMELLOSE SODIUM
  • STARCH, CORN
  • TITANIUM DIOXIDE

ASPIRIN 
aspirin tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-0030(NDC:49483-011)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
CROSCARMELLOSE SODIUM 
HYPROMELLOSES 
CELLULOSE, MICROCRYSTALLINE 
MINERAL OIL 
TITANIUM DIOXIDE 
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize10mm
FlavorImprint CodeTCL011
Contains    
Packaging
#Item CodePackage Description
1NDC:70518-0030-030 TABLET, COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34312/01/2016
Labeler - REMEDYREPACK INC. (829572556)

 
REMEDYREPACK INC.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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