DrugCite

ASPIRIN  - aspirin tablet 
Rugby Laboratories Inc.

Aspirin Tablets (NSAID)
* nonsteroidal anti-inflammatory drug

Active Ingredient

(in each tablet)

Aspirin 81 mg

Purpose

Pain Reliever

Uses

  • Temporarily relieves minor aches and pains
  • For other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur.

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 signs 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 an NSAID, which may cause severe stomach bleeding.

    The chances 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 non-prescription NSAIDs (ibuprofen, naproxen, or others)
  • take more or for longer time than directed
  • have 3 or more alcoholic drinks every day while using this product

    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 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 lasts more than 3 days
  • redness or swelling is present in the painful area
  • any symptoms appear
  • ringing in the ears or loss of hearing occurs

    If pregnant or breast feeding,  ask a health professional before use. It is especially important not to use aspirin during the last three months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complication 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 & older: take 4 or 8 tablets every 4 hours while symptoms last, but not more than 48 tablets in 24 hours
  • children under 12 years: ask a doctor

Other Information

  • store at room temperature 15°-30°C (59°-86°F)

Inactive Ingredients

croscarmellose sodium, D&C Yellow # 10 (AL-lake), HPMC, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol/propylene glycol, PVP, silicon dioxide, sodium lauryl sulfate, corn starch, stearic acid, talc, titanium dioxide

Questions or Comments

Call 1-800-645-2158, 9am–5pm ET, Monday - Friday

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

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NDC 0536-3086-41

Rugby

Enteric Coated

Aspirin 81 mg Tablets (NSAID)
Analgesic

120 Tablets

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NDC 0536-3086-10

Rugby

Enteric Coated

Aspirin 81 mg Tablets (NSAID)
Analgesic

1000 Tablets


ASPIRIN 
aspirin  tablet
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 0536-3086
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
CROSCARMELLOSE SODIUM  
D&C YELLOW NO. 10  
HYPROMELLOSES  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A  
CELLULOSE, MICROCRYSTALLINE  
PROPYLENE GLYCOL  
POVIDONE K30  
SILICON DIOXIDE  
SODIUM LAURYL SULFATE  
STARCH, CORN  
STEARIC ACID  
TALC  
TITANIUM DIOXIDE  
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 8mm
Flavor Imprint Code AP;121
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 0536-3086-41 120 TABLET In 1 BOTTLE None
2 0536-3086-10 1000 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part343 04/28/2008

Labeler - Rugby Laboratories Inc. (191427277)
Registrant - Advance Pharmaceutical Inc. (078301063)
Establishment
Name Address ID/FEI Operations
Advance Pharmaceutical Inc. 078301063 MANUFACTURE
Revised: 12/2012Rugby Laboratories Inc.