FDA Label for Aspirin
View Indications, Usage & Precautions
Aspirin Product Label
The following document was submitted to the FDA by the labeler of this product Cardinal Health. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Hospak® Unit Dose Products
Drug Facts
ASPIRIN 325 mg (5gr) (NSAID)*
*nonsteroidal anti-inflammatory drug
MICRO-COATED TABLETS
Active Ingredient
Aspirin 325 mg (in each tablet)
Purpose
Pain reliever
Uses
See product insert for uses, directions, prescribing information, precautions and warnings.
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 sign of Reye’s syndrome, a rare but serious illness.
Do not use if you are allergic to aspirin or any other pain reliever/ fever reducer
Warning:
This Unit Dose package is not child resistant and is Intended for Institutional Use Only.
Stop use and ask a doctor if
• pain or fever persists or gets worse• redness or swelling is present• new or unexpected symptoms occur• ringing in the ears or loss of hearing occurs
These could be signs of a serious condition.
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 SPECIFICALLY DIRECTED TO DO SO BY A DOCTOR BECAUSE IT MAY CAUSE PROBLEMS IN THE UNBORN CHILD OR COMPLICATIONS DURING DELIVERY.
Directions
Do not exceed recommended dosage
Adults and children 12 years and older:
• take 1 or 2 tablets with water every 4 hours• Do not exceed 12 tablets in 24 hours unless directed by a doctor
children under 12 years: consult a doctor.
Keep Out Of Reach Of Children
Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Inactive Ingredients
corn starch, croscarmellose sodium, hypromellose, microcrystalline cellulose, mineral oil, titanium dioxide
Other Information
• Do not use if packet is torn, cut or opened.• Store at 25C (77F) excursions permitted between 15-30C (59-86F)• use by expiration date on packageIf 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.
Mfg. by: Time-Cap Labs Inc., Farmingdale, NY 11735
Dist. By: Hospak® Unit Dose Products, Rockford, IL 61114
Repackaged By
Cardinal Health
Zanesville, OH 43701
L42652450816
Principal Display Panel
Aspirin 325 mg
10 Micro-Coated Tablets
* Please review the disclaimer below.