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Name:Adult Low Dose Aspirinenteric Safety Coated
Manufacturer:Zandi Llc
Category:Over-the-counter (OTC) Marketed Drugs


DRUG FACTS

ADULT LOW DOSE ASPIRIN ENTERIC SAFETY COATED - aspirin tablet, delayed release 
Zandi LLC

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.

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DRUG FACTS

Active ingredient (in each tablet)                   Purpose
Aspirin 81 mg (NSAID*)................................Pain reliever
*nonsteroidal anti-inflammatory drug

Uses
  • for the temporarily relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product may not provide fast relief of headache or other symptoms needing immediate relief.
  • ask your doctor about other uses of 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
  • facial swelling
  • shock
  • 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 are taking a diuretic
  • you have asthma

Ask a doctor or pharmacist before use if you are
  • taking a prescription drug for:
  • gout, or 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
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present in the painful area
  • any new symptoms appear
  • ringing in the ears or a loss of hearing occurs
These could be signs of a serious condition.

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
  • drink a full glass of water with each dose
  • adults and children 12 years and over: take 4 to 8 tablets every 4 hours; do not exceed 48 tablets in 24 hours unless directed by a doctor
  • children under 12 years: consult a doctor

  • store between 20° - 25°C (60° - 77°F) in a dry place

Inactive ingredients anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D & C yellow # 10, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

IMAGE OF BOTTLE LABEL

ADULT LOW DOSE ASPIRIN  ENTERIC SAFETY COATED
aspirin tablet, delayed release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:75942-001
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPIRIN (ASPIRIN) ASPIRIN 81 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE  
CARNAUBA WAX  
SILICON DIOXIDE  
CROSCARMELLOSE SODIUM  
D&C YELLOW NO. 10  
FERRIC OXIDE YELLOW  
METHACRYLIC ACID  
CELLULOSE, MICROCRYSTALLINE  
POLYSORBATE 80  
DIMETHICONE  
SODIUM HYDROXIDE  
SODIUM LAURYL SULFATE  
TALC  
TITANIUM DIOXIDE  
TRIETHYL CITRATE  
Product Characteristics
Color yellow Score no score
Shape ROUND Size 7mm
Flavor Imprint Code embossed;upper;8;lower;plain
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:75942-001-12 120 TABLET, DELAYED RELEASE ( TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:75942-001-36 360 TABLET, DELAYED RELEASE ( TABLET) in 1 BOTTLE, PLASTIC None
3 NDC:75942-001-50 500 TABLET, DELAYED RELEASE ( TABLET) in 1 BOTTLE, PLASTIC None
4 NDC:75942-001-75 750 TABLET, DELAYED RELEASE ( TABLET) in 1 BOTTLE, PLASTIC None
5 NDC:75942-001-10 1000 TABLET, DELAYED RELEASE ( TABLET) in 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part343 01/18/2011

Labeler - Zandi LLC (784431590)

Revised: 01/2011 Zandi LLC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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