DIRECT SAFETY IBUPROFEN- ibuprofen 200 mg tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)

Available from:

Conney Safety Products, LLC

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Pain reliever/fever reducer Temporarily relieves minor aches and pains associated with ■ headache ■ toothache ■ backache ■ menstrual cramps ■ common cold ■ muscular aches ■ minor arthritis pain Temporarily reduces fever.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DIRECT SAFETY IBUPROFEN- IBUPROFEN 200 MG TABLET, FILM COATED
CONNEY SAFETY PRODUCTS, LLC
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DIRECT SAFETY IBUPROFEN
_DRUG FACTS_
_ACTIVE INGREDIENT (IN EACH TABLET)_
Ibuprofen 200 mg
(NSAID*)...........................................................
*nonsteroidal anti-inflammatory drug
_PURPOSE_
Pain reliever/fever reducer
_USES_
TEMPORARILY RELIEVES MINOR ACHES AND PAINS ASSOCIATED WITH
■ headache ■ toothache ■ backache ■ menstrual cramps
■ common cold ■ muscular aches ■ minor arthritis pain
TEMPORARILY REDUCES FEVER.
_WARNINGS_
ALLERGY ALERT:
Ibuprofen may cause a severe allergic reaction, especially in people
allergic to aspirin. Symptoms may
include:
■ hives ■ skin reddening ■ asthma (wheezing) ■ facial swelling
■ rash ■ shock ■ blisters
If an allergic reaction occurs, stop use and seek medical help right
away.
STOMACH BLEEDING WARNING:
This product contains an NSAID, which may cause severe 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 prescription or nonprescription NSAIDs
(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
HEART ATTACK OR STROKE WARNING:
NSAIDS, except aspirin, increase the risk of heart attack, heart
failure, and stroke. These can be fatal.
The risk is higher if you use more than directed or for longer than
directed.
DO NOT USE
■ if you have ever had an allergic 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 or fever reducers
■ stomach bleeding warning applies to you
■ you have a history of stomach problems such as heartburn
■ you have high blood pressure, heart disease, liver cirrhosis,
kidney disease, asthma or had a stroke
■ you a