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Aspirin by Rugby Laboratories Inc.

Dosage form: tablet
Ingredients: ASPIRIN 81mg
Labeler: Rugby Laboratories Inc.
NDC Code: 0536-3297

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.

Children’s Aspirin (NSAID)

Active Ingredient

(in each tablet)

Aspirin 81 mg (NSAID)

*nonsteroidal anti-inflammatory drug

Purpose

Pain Reliever

Use
  • temporarily relieves minor aches and pains

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
  • asthma (wheezing)
  • shock
  • facial swelling

    Stomach Bleeding Warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if your child

  • has had stomach ulcers or bleeding problems
  • take a blood-thinning (anticoagulant) or steroid drug
  • takes other drugs containing prescription or nonprescription NSAIDs (ibuprofen, naproxen, others)
  • takes more or for a longer time than directed

    Do not use

  • if the child has ever had an allergic reaction to any other pain reliever / fever reducer
  • for at least 7 days after tonsillectomy or oral surgery

    Ask a doctor before use if

  • stomach bleeding warning applies to your child
  • child has a history of stomach problems, such as heartburn
  • child has not been drinking fluids
  • child has lost a lot of fluid due to vomiting and diarrhea
  • child has high blood pressure, heart disease, lever cirrhosis, or kidney disease
  • child is taking a diuretic
  • child has asthma

    Ask a doctor or pharmacist before use if the child is

  • taking a prescription drug for diabetes, gout or arthritis
  • taking any other drug
  • under a doctor’s care for any serious condition

    Stop use and ask a doctor if

  • child experiences any of the following signs of stomach bleeding:
  • feels faint
  • vomits blood
  • has bloody or black stools
  • has stomach pain that does not get better
  • pain gets worse or lasts more than 5 days
  • any new symptoms appear
  • redness or swelling is present in the painful area
  • ringing in the ears or a loss of hearing occurs

    Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.

Directions
  • this product does not contain directions or complete warnings for adult use
  • administer only under adult supervision
  • if possible, use weight to dose, otherwise use age
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 doses in 24 hours
  • drink water with each dose
Weight (lbs.)Age (years)Dose
77 – 8311 to under 124 – 6 tablets
66 – 769 to under 114 - 5 tablets
46 – 656 to under 94 tablets
36 – 454 to under 63 tablets
32 – 353 to under 42 tablets
under 32under 3ask a doctor

Other Information

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

Inactive Ingredients

corn starch, FD&C Yellow #6 alum. lake, magnesium stearate, orange flavor, silicon dioxide, sugar

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.

NDC 0536-3297-36

Children’s Aspirin (NSAID) 11/4 gr (81 mg)
Pain Reliever

Chewable Orange Flavor

36 Tablets

Rugby Duluth, Georgia 30097

ASPIRIN 
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-3297
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
FD&C YELLOW NO. 6 
MAGNESIUM STEARATE 
ORANGE 
SILICON DIOXIDE 
SUCROSE 
Product Characteristics
ColorYELLOWScoreno score
ShapeROUNDSize8mm
FlavorORANGEImprint CodeAP;009
Contains    
Packaging
#Item CodePackage Description
1NDC:0536-3297-3636 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34301/23/1998
Labeler - Rugby Laboratories Inc. (191427277)
Registrant - Advance Pharmaceutical Inc. (078301063)
Establishment
NameAddressID/FEIOperations
Advance Pharmaceutical Inc.078301063MANUFACTURE(0536-3297)

 
Rugby Laboratories Inc.

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Medically reviewed on Dec 10, 2018

Further information

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

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