DrugCite

ASCRIPTIN REGULAR STRENGTH BUFFERED ASPIRIN - aspirin tablet, film coated 
Novartis Consumer Health, Inc.

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


ASCRIPTIN  REGULAR STRENGTH BUFFERED ASPIRIN
aspirin  tablet, film coated
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 0067-0149
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPIRIN (ASPIRIN) ASPIRIN 325 mg
Inactive Ingredients
Ingredient Name Strength
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
Color WHITE Score no score
Shape ROUND Size 11mm
Flavor Imprint Code ASCRIPTIN
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 0067-0149-10 1 BOTTLE In 1 CARTON contains a BOTTLE
1 100 TABLET In 1 BOTTLE This package is contained within the CARTON (0067-0149-10)
2 0067-0149-22 1 BOTTLE In 1 CARTON contains a BOTTLE
2 225 TABLET In 1 BOTTLE This package is contained within the CARTON (0067-0149-22)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part343 09/24/2009

Labeler - Novartis Consumer Health, Inc. (879821635)
Revised: 01/2010Novartis Consumer Health, Inc.