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Aspirin by Yichang Humanwell Pharmaceutical Co. Ltd.

Medically reviewed on May 8, 2017

Dosage form: tablet, film coated
Ingredients: ASPIRIN 81mg
Labeler: Yichang Humanwell Pharmaceutical Co. Ltd.
NDC Code: 62732-8005

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.

FM Aspirin 81mg Enteric CTD Tab

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.

  • ask your doctor about other uses for this product

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
  • shock
  • facial swelling
  • asthma (wheezing)

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 are allergic to aspirin or any other pain reliever/fever reducer.

Ask a doctor before use if

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

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: •feel faint •have bloody or black stools •vomit blood •have stomach pain that does not get better
  • any new symptoms occur
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present
  • ringing in the ears or a loss of hearing occurs

These could be signs of a serious illness.

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 accidental overdose, get medical help or contact a poison control center right away.

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 15-25ºC (59-77ºF)
  • protect from heat, humidity, and light

Inactive ingredients

colloidal anhydrous silica, corn starch, D&C yellow #10 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #5 aluminum lake, ferrosoferric oxide, glyceryl monostearate, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, polyvinyl acetate phthalate, polyvinyl alcohol, povidone, pregelatinized starch, shellac, sodium bicarbonate, sodium lauryl sulfate, talc, triethyl citrate, and titanium dioxide.

Quantity: 70,000 Tablets

NDC No.: 62732-8005-1

ASPIRIN 
aspirin tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62732-8005
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 6000 
SILICON DIOXIDE 
FD&C YELLOW NO. 5 
CELLULOSE, MICROCRYSTALLINE 
TALC 
POLYVINYL ACETATE PHTHALATE 
TITANIUM DIOXIDE 
GLYCERYL MONOSTEARATE 
SODIUM LAURYL SULFATE 
FD&C BLUE NO. 2 
SHELLAC 
SODIUM BICARBONATE 
METHACRYLIC ACID 
TRIETHYL CITRATE 
STARCH, CORN 
D&C YELLOW NO. 10 
FERROSOFERRIC OXIDE 
POVIDONE 
POLYVINYL ALCOHOL 
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize7mm
FlavorImprint Code81E
Contains    
Packaging
#Item CodePackage Description
1NDC:62732-8005-170000 TABLET, FILM COATED in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34312/14/2016
Labeler - Yichang Humanwell Pharmaceutical Co. Ltd. (527225336)

 
Yichang Humanwell Pharmaceutical Co. Ltd.

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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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