MUCINEX CHILDRENS STUFFY NOSE AND CHEST CONGESTION- guaifenesin and phenylephrine hydrochloride solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ), Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV)

Available from:

RB Health (US) LLC

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive - temporarily relieves: nasal congestion due to a cold stuffy nose - nasal congestion due to a cold - stuffy nose

Authorization status:

OTC monograph final

Summary of Product characteristics

MUCINEX CHILDRENS STUFFY NOSE AND CHEST CONGESTION- GUAIFENESIN
AND PHENYLEPHRINE HYDROCHLORIDE SOLUTION
RB HEALTH (US) LLC
_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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MUCINEX® CHILDREN'S
STUFFY NOSE & CHEST CONGESTION
_DRUG FACTS_
_ACTIVE INGREDIENTS (IN EACH 5_
_ML)_
_PURPOSES_
Guaifenesin 100 mg
Expectorant
Phenylephrine HCl 2.5 mg
Nasal decongestant
USES
helps loosen phlegm (mucus) and thin bronchial secretions to rid the
bronchial
passageways of bothersome mucus and make coughs more productive
temporarily relieves:
nasal congestion due to a cold
stuffy nose
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 THE CHILD HAS
heart disease
high blood pressure
thyroid disease
diabetes
cough that occurs with too much phlegm (mucus)
persistent or chronic cough such as occurs with asthma
WHEN USING THIS PRODUCT DO NOT USE MORE THAN DIRECTED
STOP USE AND ASK A DOCTOR IF
nervousness, dizziness, or sleeplessness occur
symptoms do not get better within 7 days or occur with fever
cough lasts more than 7 days, comes back, or occurs with fever, rash,
or persistent
headache. These could be signs of a serious condition.
KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help
or contact a
Poison Control Center right away.
DIRECTIONS
do not give more than 6 doses in any 24-hour period
measure only with dosing cup provided
do not use dosing cup with other products
dose as follows or as directed by a doctor
AGE
DOSE
children 6 to under 12
years of age
10 mL every 4
hours
children 4 to under 6
years of age
5 mL ev