DrugCite

ASPIRIN  - aspirin tablet, chewable 
Advance Pharmaceutical Inc.

ASPIRIN 81mg

Active Ingredient

(in each tablet)

Aspirin 81 mg (NSAID) *

*nonsteroidal anti-inflammatory drug

Purpose

Pain Reliever

Use

  • 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 effect 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
  • 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

    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

  • 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 – 83 11 to under 12 4 – 6 tablets
    66 – 76 9 to under 11 4 - 5 tablets
    46 – 65 6 to under 9 4 tablets
    36 – 45 4 to under 6 3 tablets
    32 – 35 3 to under 4 2 tablets
    under 32 under 3 ask a doctor

    DRINK A FULL GLASS OF WATER WITH EACH DOSE

  • adults and children 12 years and older : take 4 to 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 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 631-981-4600, 8.30am – 4.30 pm ET Monday-Friday

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

Manufactured by: Advance Pharmaceutical, Inc. Holtsville, NY 11742

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

655159bb-figure-01
655159bb-figure-02

NDC: 17714-009-36 – 36 COUNT


ASPIRIN 
aspirin  tablet, chewable
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 17714-009
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
STARCH, CORN  
FD&C YELLOW NO. 6  
MAGNESIUM STEARATE  
ORANGE  
SILICON DIOXIDE  
SUCROSE  
Product Characteristics
Color ORANGE Score score with uneven pieces
Shape ROUND Size 8mm
Flavor ORANGE Imprint Code AP;009
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 17714-009-36 36 TABLET In 1 BOTTLE contains a CARTON
1 1 BOTTLE In 1 CARTON This package is contained within the BOTTLE (17714-009-36)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part343 04/15/1988

Labeler - Advance Pharmaceutical Inc. (078301063)
Registrant - Advance Pharmaceutical Inc. (078301063)
Establishment
Name Address ID/FEI Operations
Advance Pharmaceutical Inc. 078301063 MANUFACTURE
Revised: 03/2013Advance Pharmaceutical Inc.