DrugCite

ASPIRIN ENTERIC SAFETY COATED - aspirin tablet, delayed release 
Avema Pharma Solutions

Aspirin

Active ingredient(in each tablet)

Aspirin 81mg (NSAID)**

**nonsteroidal anti- inflammatory drug

Purpose

 Pain reliever

Uses

  •  temporarily relieves minor aches and pains
  • other therapy as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches, fever, or other symptoms needing immediate relief.

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 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 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:

  • anticoagulation (thinning of the blood)
  • gout
  • diabetes
  • arthritis

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

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 exceed recommended dosage
  • drink a full glass of water with each dose
  • adults and children 12 years of age 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 of age: consult a doctor

Other information

  • store at controlled room temperature 15°-30°C (59°-86°F)
  • do not use if imprinted safety seal under cap is broken or missing
  • †This product is not manufactured or distributed by Bayer Corporation Consumer Care Division, owner of the registered trademark Aspirin Regimen Bayer® 81 mg

Inactive ingredients

acetylated monoglycerides*, anhydrous lactose*, carnauba wax*, colloidal silicon dioxide,corn starch*, croscarmellose sodium*, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, hypromellose, hypromellose phthalate*, iron oxide Yellow (iron
oxide ochre)*, methacrylic acid copolymer, microcrystalline cellulose, *mineral oil, polyethylene glycol (PEG)-400*, polysorbate 80*, povidone, pregelatinized starch, propylene glycol*, simethicone*, silicon dioxide, sodium bicarbonate, sodium hydroxide, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide, triacitin, and triethyl citrate. *contains one or more of these ingredients

Questions or comments?

Call toll free 1-877-753-3935 Monday-Friday 9AM-5PM EST

Package Label

 PLD Miami Aspirin 81mg 300 count

Aspirin 81mg 300 count


ASPIRIN  ENTERIC SAFETY COATED
aspirin  tablet, delayed release
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 63548-0046
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
DIACETYLATED MONOGLYCERIDES  
ANHYDROUS LACTOSE  
CARNAUBA WAX  
SILICON DIOXIDE  
STARCH, CORN  
CROSCARMELLOSE SODIUM  
FD&C YELLOW NO. 6  
HYPROMELLOSES  
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)  
FERRIC OXIDE YELLOW  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)  
CELLULOSE, MICROCRYSTALLINE  
MINERAL OIL  
POLYETHYLENE GLYCOL 400  
POLYSORBATE 80  
POVIDONE  
STARCH, CORN  
propylene glycol  
DIMETHICONE  
SILICON DIOXIDE  
SODIUM BICARBONATE  
SODIUM HYDROXIDE  
SODIUM LAURYL SULFATE  
STARCH, CORN  
STEARIC ACID  
TALC  
TITANIUM DIOXIDE  
TRIACETIN  
TRIETHYL CITRATE  
Product Characteristics
Color YELLOW (ENTERIC COATED PEACH) Score no score
Shape ROUND Size 10mm
Flavor Imprint Code E;heart;81
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 63548-0046-1 300 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 08/11/2022

Labeler - Avema Pharma Solutions (804087794)
Establishment
Name Address ID/FEI Operations
Avema Pharma Solutions 804087794 MANUFACTURE
Revised: 07/2012Avema Pharma Solutions