Ascriptin Regular Strength Buffered Aspirin

Dosage form: tablet, film coated
Ingredients: ASPIRIN 325mg
Labeler: Novartis Consumer Health, Inc.
NDC Code: 0067-0149

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.

Drug Facts

Active ingredient(in each tablet)  

Buffered aspirin equal to 325 mg aspirin (NSAID)*

(buffered with aluminum hydroxide, calcium carbonate, and magnesium hydroxide)

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses
  • for the temporary relief of minor aches and pains associated with:
    • arthritis
    • headache
    • muscular aches
    • toothache
    • premenstrual & menstrual cramps
    • cold

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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause 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 an NSAID (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 aspirin or any other pain reliever/fever reducer

Ask a doctor before use if you have
  •  stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain
  • ulcers
  • bleeding problems
  • high blood pressure
  • heart or kidney disease
  • taken a diuretic
  • reached age 60 or older
  • asthma

Ask a doctor or pharmacist before use if you are taking:
  • any other drug containing an NSAID (prescription or nonprescription)
  • a blood thinning (anticoagulant) or steroid drug
  • a prescription drug for diabetes, gout, or arthritis
  • any other drug, or are under a doctor’s care for any serious condition

 

Stop use and ask a doctor if
  • an allergic reaction occurs. Seek medical help right away.
  • you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding.
  • stomach pain or upset gets worse or lasts
  • ringing in the ears or loss of hearing occurs
  • painful area is red or swollen
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days
  • any new symptoms appear

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.

Directions
  • do not use more than directed
  • drink a full glass of water with each dose
  • adults and children 12 years and over: take 2  tablets every 4 hours while symptoms persist; not more than 12 tablets in 24 hours
  • children under 12 years: ask a doctor

Other information
  • each tablet contains: calcium 70 mg, and magnesium 10 mg
  • store at controlled room temperature 200 -  250 C (680 -  770 F)
  • protect from moisture and excessive heat 

Inactive ingredients

Inactive ingredients carnauba wax, corn starch, croscarmellose sodium, FD&C red #40 lake, granular sugar, hypromellose, magnesium stearate, mannitol, methylparaben, microcrystalline cellulose, pregelatinized starch, propylene glycol, shellac, sodium saccharin, sorbitol, talc, titanium dioxide

Questions or comments?  

1-800-452-0051

Novartis Consumer Health, Inc.

200 Kimball Drive

Parsippany, NJ 07054-0622

Package Label

Ascriptin

ASCRIPTIN  REGULAR STRENGTH BUFFERED ASPIRIN
aspirin tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-0149
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
ALUMINUM HYDROXIDE 
CALCIUM CARBONATE 
MAGNESIUM 
MAGNESIUM HYDROXIDE 
CARNAUBA WAX 
STARCH, CORN 
CROSCARMELLOSE SODIUM 
FD&C RED NO. 40 
SUCROSE 
HYPROMELLOSE 
MAGNESIUM STEARATE 
MANNITOL 
METHYLPARABEN 
CELLULOSE, MICROCRYSTALLINE 
PROPYLENE GLYCOL 
SHELLAC 
SACCHARIN SODIUM 
SORBITOL 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize11mm
FlavorImprint CodeASCRIPTIN
Contains    
Packaging
#Item CodePackage Description
1NDC:0067-0149-101 BOTTLE (BOTTLE) in 1 CARTON
1100 TABLET, FILM COATED (TABLET) in 1 BOTTLE
2NDC:0067-0149-221 BOTTLE (BOTTLE) in 1 CARTON
2225 TABLET, FILM COATED (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34309/24/2009
Labeler - Novartis Consumer Health, Inc. (879821635)

Revised: 01/2010
 
Novartis Consumer Health, Inc.

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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