Ibuprofen and Pseudoephedrine hydrochloride

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM), PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)

Available from:

Bryant Ranch Prepack

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

temporarily relieves these symptoms associated with the common cold or flu:

Product summary:

NDC: 63629-5284-1: 30 Tablets in a BOTTLE NDC: 63629-5284-2: 20 Tablets in a BOTTLE

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE- IBUPROFEN AND
PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED
BRYANT RANCH PREPACK
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IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE
_DRUG FACTS_
_ACTIVE INGREDIENTS (IN EACH_
_CAPLET)_
_PURPOSES_
*
Ibuprofen, USP 200 mg
(NSAID)
Pain reliever/fever
reducer
Pseudoephedrine HCl, USP 30
mg
Nasal decongestant
USES
temporarily relieves these symptoms associated with the common cold or
flu:
•
•
•
•
•
WARNINGS
ALLERGY ALERT
Ibuprofen may cause a severe allergic reaction, especially in people
allergic to aspirin.
Symptoms may include:
•
•
•
•
•
•
•
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:
•
nonsteroidal anti-inflammatory drug
*
headache
fever
sinus pressure
nasal congestion
minor body aches and pains
hives
facial swelling
asthma (wheezing)
shock
skin reddening
rash
blisters
are age 60 or older
•
•
•
•
•
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
•
•
•
•
ASK A DOCTOR BEFORE USE IF
•
•
•
•
•
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
•
•
•
•
WHEN USING THIS PRODUCT
•
STOP USE AND ASK A DOCTOR IF
•
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
in children under 12 years of age
if you have ever had an allergic reaction to any other pain
reliever/fever reducer
right before or after heart surgery
if you are now taking a prescription monoamine oxidase inhibitor
(MAOI) (certain
drugs for depression,