TRIACTING DAYTIME COLD 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:

AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385

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 DAYTIME COLD COUGH CHILDRENS- DEXTROMETHORPHAN HBR,
PHENYLEPHRINE
HCL LIQUID
AMERISOURCEBERGEN DRUG CORPORATION (GOOD NEIGHBOR PHARMACY) 24385
_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 INGREDIENTS (IN EACH 5 ML, 1 TEASPOON)
Dextromethorphan HBr, USP 5 mg
Phenylephrine HCl, USP 2.5 mg
PURPOS E
Cough suppressant
Nasal decongestant
US ES
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
take every 4 hours; not to exceed 6 doses in any 24-hour period or as
directed by a doctor
use enclosed dosage cup
tsp=teaspoon, mL=milliliter
age
dose
children 6 to under 12 years of age
2 teaspoons(10 mL)
children 4 to 5 years
1 teaspoon (5 mL)
children unde