CARBAPHEN PED CH chlophedianol hcl chlorpheniramine maleate and phenylephrine suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CHLOPHEDIANOL HYDROCHLORIDE (UNII: 69QQ58998Y) (CHLOPHEDIANOL - UNII:42C50P12AP)

Available from:

Gil Pharmaceutical Corp

INN (International Name):

CHLOPHEDIANOL HYDROCHLORIDE

Composition:

CHLOPHEDIANOL HYDROCHLORIDE 8 mg in 1 mL

Prescription type:

OTC DRUG

Authorization status:

OTC monograph final

Summary of Product characteristics

CARBAPHEN PED CH- CHLOPHEDIANOL HCL, CHLORPHENIRAMINE MALEATE AND
PHENYLEPHRINE
HCL SUSPENSION
GIL PHARMACEUTICAL CORP
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if they_
_comply with applicable regulations and policies. FDA has not
evaluated whether this product complies._
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DRUG FACTS
ACTIVE INGREDIENT (IN EACH 1 ML)
Chlophedianol HCl 8 mg
Chlorpheniramine Maleate 1.25 mg
Phenylephrine HCl 2.5 mg
PURPOS E
Antitussive
Antihistamine
Nasal Decongestant
US ES
Temporarily relieves:
cough due to the common cold.
runny nose and sneezing, itching of the nose or throat, and itchy,
watery eyes due to hay fever or
other upper respiratory allergies.
nasal congestion due to the common cold.
WARNINGS
DO NOT USE
in a child who is taking a prescription monoamine oxidase inhibitor
(MAOI) (certain drugs for
depression, psychiatric, or emotional conditions, or Parkinson's
disease), or for 2 weeks after
stopping the MAOI drug. If you do not know if your child's
prescription drug contains an MAOI, ask
a doctor or pharmacist before giving this product.
ASK A DOCTOR BEFORE USE IF YOU HAVE
asthma
emphysema
glaucoma
diabetes
excessive phlegm (mucus)
breathing problems
chronic bronchitis
persistent or chronic cough
cough associated with smoking
trouble urinating due to enlarged prostate gland
a sodium-restricted diet
thyroid disorders
heart disease
high blood pressure
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
taking sedatives or tranquilizers
WHEN USING THIS PRODUCT
DO NOT USE MORE THAN DIRECTED
excitability may occur, especially in children
marked drowsiness may occur
avoid alcoholic drinks
be careful when driving a motor vehicle or operating machinery
alcohol, sedatives, and tranquilizers may increase drowsiness
STOP USE AND ASK A DOCTOR IF
cough lasts more than 7 days, comes back, or occurs with fever, rash,
headache that lasts, or
sleeplessness. These could be signs of a serious condition.
IF PREGNANT OR BREAST-FEEDING,
ask a health professional before use.
KEEP OUT