Active Ingredient (In Each Tablet)

Aspirin 81 mg

Purpose

Pain Reliever/Fever Reducer

Uses

For temporary relief of minor aches and pains

Warnings:

Reye's syndrome: Children and teenagers should not use this medicine
for chicken pox or flu symptoms before a doctor is consulted about
Reye's syndrome, a rare but serious illness reported to be associated
with aspirin.

Alcohol Warning: If you consume 3 or more alcoholic drinks every day, ask
your doctor whether you should take aspirin or other pain relievers/fever
reducers. Aspirin may cause stomach bleeding.

If you are allergic to aspirin

With any other pain reliever/fever reducer

If you have ever had an allergic reaction to any other pain reliever/fever reducer

For pain for more than 10 days or for fever for more than 3 days unless directed by a doctor

With any other product containing aspirin

Ask doctor before using if you have:

Asthma
Bleeding problems
Stomach problems (such as heartburn, upset stomach or stomach pain) gastric ulcers

Ask a doctor or pharmacist before use if you are taking a prescription drug for:

Anticoagulation (thinning of blood)
Diabetes
Gout
Arthritis

Stop use and ask a doctor if:

Ringing in the ears or loss of hearing occurs
Pain or fever persists or gets worse
New symptoms occur
Redness or swelling is present

If pregnant or breast-feeding baby,

ask a health professional before use. IT IS ESPECIALLY IMPORTANT NOT TO USE ASPIRIN DURING THE LAST 3 MONTHS OF PREGNANCY UNLESS SPECIFICALLY 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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Directions: Remove tablet from backing by bending at perforation and
peeling back cover. Place tablet on tongue and allow saliva to dissolve the
tablet for rapid absorption.
Adults: Take 1 tablet daily, do not exceed 36 tablets in 24 hours, or as
directed by a doctor. Children: Consult a doctor.

Inactive Ingredients:

Citric Acid, Crospovidone, D and C Yellow #10, Flavor, Glucosamine Sulfate-K, Mannitol, Sodium Stearyl Fumarate, Sorbitol, Sunnette K, Zinc Gluconate

Manufactured for: Nobel Laboratories, LLC

3413 Spanish Oak Drive Austin, TX 787314

www.NobelLabs.com

Store Product Below 90 degrees F. Protect from heat, light and moisture.

U.S Patents 6,596,708 / 6,930,099 and Patents Pending

Package Label Section

image of carton label

FASPRIN
aspirin tablet, orally disintegrating

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10597-559
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CROSPOVIDONE (UNII: 68401960MK)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
GLUCOSAMINE (UNII: N08U5BOQ1K)
MANNITOL (UNII: 3OWL53L36A)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
SORBITOL (UNII: 506T60A25R)
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)

Product Characteristics
Color	yellow (yellow)	Score	no score
Shape	ROUND (Round)	Size	9mm
Flavor		Imprint Code	F
Contains

#	Item Code	Package Description
Packaging
1	NDC:10597-559-05	30 in 1 BOX
2	NDC:10597-559-06	100 in 1 BOX

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part343	09/20/2006

Labeler - Nobel Laboratories, LLC (022735189)

Name	Address	ID/FEI	Business Operations
Establishment
Avema Pharma Solutions		804087794	manufacture

Drug Facts