CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE- chlorpheniramine maleate and phenylephrine hydrochloride tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)

Available from:

AAA Pharmaceutical, Inc.

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

- temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies: runny nose sneezing itchy, watery eyes nasal congestion itching of the nose or throat - runny nose - sneezing - itchy, watery eyes - nasal congestion - itching of the nose or throat - temporarily relieves these symptoms due to the common cold: runny nose sneezing nasal congestion - runny nose - sneezing - nasal congestion

Authorization status:

OTC monograph final

Summary of Product characteristics

CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE-
CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE TABLET,
COATED
AAA PHARMACEUTICAL, INC.
_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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RES - 1158 - 2019-0911
_DRUG FACTS_
_ACTIVE INGREDIENTS (IN_
_EACH TABLET)_
_PURPOSE_
Chlorpheniramine maleate
4 mg
Antihistamine
Phenylephrine HCl 10 mg
Nasal decongestant
USES
temporarily relieves these symptoms due to hay fever (allergic
rhinitis) or other upper
respiratory allergies:
runny nose
sneezing
itchy, watery eyes
nasal congestion
itching of the nose or throat
temporarily relieves these symptoms due to the common cold:
runny nose
sneezing
nasal congestion
WARNINGS
DO NOT USE if you are now 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
prescription drug contains an MAOI, ask a doctor or pharmacist before
taking this
product.
ASK A DOCTOR BEFORE USE IF YOU HAVE
high blood pressure
heart disease
thyroid disease
diabetes
glaucoma
trouble urinating due to an enlarged prostate gland
a breathing problem such as emphysema or chronic bronchitis
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE taking sedatives or
tranquilizers
WHEN USING THIS PRODUCT
DO NOT EXCEED RECOMMENDED DOSAGE
excitability may occur, especially in children
drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery
STOP USE AND ASK A DOCTOR IF
nervousnous, dizziness, or sleeplessness occurs
symptoms do not improve within 7 days or occur with fever
IF PREGNANT OR BREAST-FEEDING, ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help
or contac