Microsoft word - drug_facts_gpsi_ibuprofen_gpsi.doc

GENERIC PHARMACEUTICAL SERVICES, INC.
DRUG FACTS GUIDE COPY
Product: IBUPROFEN 200 MG TABLET (BROWN) Dist. by: Name, city, state, zip code 2 tablets per packet DRUG FACTS
Active Ingredient (in each brown tablet) Purpose
200 mg (NSAID)* ………………………………………………..Pain Reliever/Fever reducer
* nonsteroidal anti-inflammatory drug
USES temporarily relieves minor aches and pains due to: headache
muscular aches minor pain of arthritis backache common cold toothache menstrual cramps temporarily reduces fever Warnings
Allergy Alert: Ibuprofen may cause a severe al ergic reaction, especial y in people al ergic to aspirin. Symptoms may include:
asthma (wheezing) shock skin reddening rash blisters If an al ergic reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach
bleeding. The chance is higher if you:
• are age 60 or older
• have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• take other drugs containing an NSAID (aspirin, ibuprofen, naproxen or others)
• have 3 or more alcoholic drinks every day while using this product
• take more or for a longer time than directed
Do not use
• if you have ever had an al ergic reaction to any other pain reliever/fever reducer
• right before or after heart surgery
Ask a doctor before use if you have
• problems or serious side effects from taking pain relievers/fever reducers
• stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain
• ulcers
• bleeding problems
• high blood pressure
• heart or kidney disease
• taken a diuretic
• reached age 60 or older
Ask a doctor or pharmacist before use if you are
• taking any other drug containing a NSAID (prescription or nonprescription)
• taking a blood thinning (anticoagulant) or steroid drug
• under a doctor’s care for any serious condition
• taking any other drug
When using this product
• take with food or milk if stomach upset occurs
• long term continuous use may increase the risk of heart attack or stroke
Stop use and ask a doctor if
you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days stomach pain or upset gets worse or lasts redness or swel ing is present in the painful area If pregnant or breast-feeding, ask a health professional before use. It is especial y important not to use Ibuprofen 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 Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
do not take more than directed
the smal est effective dose should be used do not take longer than 10 days, unless directed by a doctor (see Warnings) take one tablet every 4 to 6 hours while symptoms persist adults and children 12 years
if pain or fever does not respond to 1 tablet , 2 tablets may be used and older
do not exceed 6 tablets in 24 hours unless directed by a doctor children under 12 years
\\Fao-fp\shared\Purchasing\RFQ_&_REV_ 2007\MSDS_Interim_Process\DRUG_FACTS_GPSI_Ibuprofen_GPSI.doc GENERIC PHARMACEUTICAL SERVICES, INC.
DRUG FACTS GUIDE COPY

Other Information
include contact information for Serious Adverse Event (SAE) reporting (domestic Read al warnings and directions before use Inactive Ingredients carnauba wax, cel ulose, corn starch, fumed silica gel, hypromel ose, lactose, magnesium
stearate, polydextrose, polyethylene glycol, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide TAMPER EVIDENT PACKETS. DO NOT USE IF OPEN OR TORN. By: ________________
Date: ________________

Check By: ________________
Date: ________________
Summary Revisions:
Revision: (12/07) Manufacturer changed from Interpharm to LNK International
Active ingredient…added “brown” tablet; added “USP” Added avoid excessive heat 40° C (104° F) Added include contact information for Serious Adverse Event (SAE) reporting (domestic address or telephone Changed to LNK’s inactive ingredients Revision: (07/07) Added brown tablet inactives-(highlighted). Final rule 9/05- no declarations required. Revision: (09/05) • New Warnings, Precautions, Directions as per FDA regulations. See further details on rev 9/05. • Inactive: deleted hydroxypropyl methylcel ulose, added hypromel ose • Final rule: 9/24/05 OTC labeling containing calcium, magnesium, potassium and sodium (actives and inactives) • Sodium = 0.575 mg, Magnesium = 0.103 mg The amounts are below the maximum limits in a single maximum recommended dose. No declaration required in "Other Information". • Sodium = 3.45 mg, Magnesium = 0.618mg The elemental concentrations do not meet the threshold and wil not \\Fao-fp\shared\Purchasing\RFQ_&_REV_ 2007\MSDS_Interim_Process\DRUG_FACTS_GPSI_Ibuprofen_GPSI.doc

Source: http://www.emisupply.com/catalog/images/UPLOAD/File/Ibuprofen-Fact-Sheet.pdf