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Aspirin by Rugby Laboratories

Medically reviewed on April 19, 2018

Dosage form: tablet
Ingredients: ASPIRIN 325mg
Labeler: Rugby Laboratories
NDC Code: 0536-1053

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.

Rugby 44-249

Active ingredient (in each tablet)

Aspirin 325 mg (NSAID)*
*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves:

  • pain and fever of colds
  • headache
  • toothache
  • muscle pain
  • minor pain of arthritis
  • menstrual pain

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 an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

  • are age 60 or older
  • take a blood thinning (anticoagulant) or steroid drug
  • have 3 or more alcoholic drinks every day while using this product
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • take more or for a longer time than directed
  • have had stomach ulcers or bleeding problems

Do not use
  • if you are allergic to aspirin or any other pain reliever/fever reducer
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if
  • you have asthma
  • you are taking a diuretic
  • 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

Ask a doctor or pharmacist before use if you are

taking a prescription drug for

  • 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
  • an allergic reaction occurs. Seek medical help right away.
  • ringing in the ears or loss of hearing occurs
  • new symptoms occur
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present
  • fever gets worse or lasts more than 3 days

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 (1-800-222-1222) right away.

Directions
  • drink a full glass of water with each dose
  • adults and children 12 years and over: take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours
  • children under 12 years: ask a doctor

Other information
  • use by expiration date on package
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

Inactive ingredient

corn starch

Questions or comments?

1-800-645-2158

Principal Display Panel

NDC 0536-1053-05

Rugby®

ASPIRIN
Pain Reliever/
Fever Reducer

(NSAID)

325 mg each

500 Tablets

AID FOR
RELIEF OF
SIMPLE HEADACHE,
COLD DISCOMFORTS,
MUSCULAR ACHES

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

Distributed by: Rugby Laboratories, 31778 Enterprise Drive,
Livonia, MI  48150
     www.rugbylaboratories.com 
R-17    Re-order No. 370396  Rev. 02/16

50844        REV0915A24914

Rugby 44-249

ASPIRIN 
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1053
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize10mm
FlavorImprint CodeASPIRIN;44;249
Contains    
Packaging
#Item CodePackage Description
1NDC:0536-1053-01100 TABLET in 1 BOTTLE
2NDC:0536-1053-05500 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34308/04/1993
Labeler - Rugby Laboratories (079246066)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(0536-1053)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837MANUFACTURE(0536-1053)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(0536-1053)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(0536-1053)

 
Rugby Laboratories

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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