TRIACTING DAY TIME COLD AND COUGH CHILDRENS- dextromethorphan hbr, phenylephrine hcl liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)

Available from:

Care One (American Sales Company)

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Cough suppressant Nasal decongestant  - temporarily relieves: nasal and sinus congestion cough due to minor throat and bronchial irritation as may occur with a cold - nasal and sinus congestion - cough due to minor throat and bronchial irritation as may occur with a cold

Authorization status:

OTC monograph final

Summary of Product characteristics

TRIACTING DAY TIME COLD AND COUGH CHILDRENS- DEXTROMETHORPHAN HBR,
PHENYLEPHRINE HCL LIQUID
CARE ONE (AMERICAN SALES COMPANY)
_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._
----------
DRUG FACTS
ACTIVE INGREDIENTS (IN EACH 5 ML)
Dextromethorphan HBr 5 mg
Phenylephrine HCl 2.5 mg
PURPOSES
Cough suppressant
Nasal decongestant
USES
temporarily relieves:
nasal and sinus congestion
cough due to minor throat and bronchial irritation as may occur with a
cold
WARNINGS
DO NOT USE
in a child under 4 years of age
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 the
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
diabetes
heart disease
thyroid disease
high blood pressure
a breathing problem such as chronic bronchitis
cough that occurs with too much phlegm (mucus)
chronic cough that lasts, or 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 occurs
symptoms do not improve within 7 days or occur with a fever
cough persists for more than 7 days, comes back or occurs with a
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 (1-800-222-
1222) right away.
DIRECTIONS
do not take more than 6 doses in any 24-hour period
measure only with dosing cup provided. Do not use any other dosing
device
keep dosing cup with product
mL = milliliter
shake well before using
age
dose
children 6 to under 12 years of age 10 mL every 4 hours
children 4 to 5 years
5 mL every 4 hours
childr