ASPIRIN tablet, chewable

Aspirin by

Drug Labeling and Warnings

Aspirin by is a Otc medication manufactured, distributed, or labeled by Advance Pharmaceutical Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

NDC: 17714-009-36 – 36 COUNT

INGREDIENTS AND APPEARANCE

ASPIRIN 
aspirin tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17714-009
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	81 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
ORANGE (UNII: 5EVU04N5QU)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	orange	Score	score with uneven pieces
Shape	ROUND	Size	8mm
Flavor	ORANGE	Imprint Code	AP;009
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17714-009-36	36 in 1 BOTTLE	04/15/1988
1		1 in 1 CARTON; Type 0: Not a Combination Product

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	Business Operations
Advance Pharmaceutical Inc.		078301063	manufacture(17714-009)