FASPRIN- aspirin tablet, orally disintegrating

Fasprin by

Drug Labeling and Warnings

Fasprin by is a Otc medication manufactured, distributed, or labeled by Nobel Laboratories, LLC, Avema Pharma Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

SPL UNCLASSIFIED SECTION

Manufactured for: Nobel Laboratories, LLC

3413 Spanish Oak Drive  Austin, TX 787314

www.NobelLabs.com

STORAGE AND HANDLING

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

INGREDIENTS AND APPEARANCE

FASPRIN 
aspirin tablet, orally disintegrating

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

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

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

Labeler - Nobel Laboratories, LLC (022735189)

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