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ASPIRIN 325 MG EC by Reliable 1 Laboratories LLC

Medically reviewed on November 1, 2017

Dosage form: tablet
Ingredients: ASPIRIN 325mg
Labeler: Reliable 1 Laboratories LLC
NDC Code: 69618-015

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.

ASPIRIN 325 MG EC TABLET

Drug Facts

Aspirin USP, 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Pain Reliever/Fever Reducer

temporarily relieves

  • headache
  • menstrual pain
  • minor pain of arthritis
  • muscle pain
  • toothache
  • pain and fever of colds

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 prodcut, 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 prodcut 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 (ibuprofen, naproxen, or others)
  • take more or for a longer time than directed
  • have 3 or more alcoholic drinks every day while using this product

Drug Facts continued on back of label

Do not use if you have ever had an allergic reaction to 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 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
  • under a doctor's care for any serious condition
  • taking any other drug

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

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasta more than 3 days
  • redness or swelling is present in the painful area
  • any new symptoms appear
  • ringing in the ears or loss of hearing occurs

These could be sings of a serious condition

If pregnant or breast-feeding, ask a health professional before use. It is especially imporant 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

  • adults and children 12 years and over: 1-2 tablets every 4 hours while symptoms last, not more than 12 tablets in 24 hours
  • children under 12 years: ask a doctor

Other information
  • store at room temperature 15°-30ºC (59°-86°F)

Inactive ingredients

croscarmellose sodium, D&C yellow #10 (Al-lake), FD&C yellow #6 (Al-lake), HPMC, methacrylic acid copolymer, polyethylene glycol, propylene glycol, povidone, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide

Questions or comments?

Questions or comments ? call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark Ecotrin®.

Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580

www.reliable1labs.com

NDC 69618-015-01

Enteric Coated

Aspirin USP 325 mg (NSAID)

PAIN RELIEVER

FEVER REDUCER

100 TABLETS

*Compare to Active Ingredients in Ecotrin®

ASPIRIN 325 MG EC 
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69618-015
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE 
METHACRYLIC ACID 
STEARIC ACID 
STARCH, CORN 
CROSCARMELLOSE SODIUM 
FD&C YELLOW NO. 6 
D&C YELLOW NO. 10 
HYPROMELLOSES 
PROPYLENE GLYCOL 
TITANIUM DIOXIDE 
TALC 
SODIUM LAURYL SULFATE 
POLYETHYLENE GLYCOL 1000 
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize10mm
FlavorImprint CodeAP;110
Contains    
Packaging
#Item CodePackage Description
1NDC:69618-015-101000 TABLET in 1 BOTTLE, PLASTIC
2NDC:69618-015-01100 TABLET in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34311/01/2015
Labeler - Reliable 1 Laboratories LLC (079718111)

 
Reliable 1 Laboratories LLC

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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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