IBUPROFEN tablet, film coated
Country: United States
Language: English
Source: NLM (National Library of Medicine)
Summary of Product characteristics
(SPC)
06-10-2023
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Active ingredient:
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)
Available from:
Bryant Ranch Prepack
INN (International Name):
IBUPROFEN
Composition:
IBUPROFEN 200 mg
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever/fever reducer - Temporarily relieves minor aches and pains due to: - headache - toothache - backache - menstrual cramps - the common cold - muscular aches - minor pain of arthritis - Temporarily reduces fever
Product summary:
NDC: 63629-1467-1: 20 Tablets in a BOTTLE NDC: 63629-1467-2: 15 Tablets in a BOTTLE NDC: 63629-1467-3: 30 Tablets in a BOTTLE NDC: 63629-1467-4: 100 Tablets in a BOTTLE NDC: 63629-1467-5: 60 Tablets in a BOTTLE NDC: 63629-1467-6: 50 Tablets in a BOTTLE NDC: 63629-1467-7: 40 Tablets in a BOTTLE NDC: 63629-1467-8: 10 Tablets in a BOTTLE NDC: 63629-1467-9: 56 Tablets in a BOTTLE NDC: 63629-1467-0: 90 Tablets in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
Authorization status:
Abbreviated New Drug Application
Summary of Product characteristics
IBUPROFEN- IBUPROFEN TABLET, FILM COATED
BRYANT RANCH PREPACK
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GC 941
ACTIVE INGREDIENT (IN EACH BROWN TABLET)
Ibuprofen USP, 200 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
PURPOSE
Pain reliever/fever reducer
USES
Temporarily relieves minor aches and pains due to:
headache
toothache
backache
menstrual cramps
the common cold
muscular aches
minor pain of arthritis
Temporarily reduces fever
WARNINGS
ALLERGY ALERT: Ibuprofen may cause a severe allergic reaction,
especially in people
allergic to aspirin. Symptoms may include:
shock
hives
facial swelling
asthma (wheezing)
skin reddening
rash
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 AND 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
the stomach bleeding warning applies to you
you have problems or serious side effects from taking pain relievers
or fever
reducers
you have a history of stomach problems, such as heartburn
you have high blood pressure, heart disease, liver cirrhosis, kidney
disease or asthma
you are taking a diuretic
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
under a doctor’s care for any serious condition
taking aspirin for heart attack or stroke, because ibuprofen may
decrease this benefit
of aspirin
taking any oth
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