SANATOS CHILDRENS MUCUS RELIEF COUGH- dextromethorphan hydrobromide and guaifenesin liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS), GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)

Available from:

Pharmadel LLC

INN (International Name):

DEXTROMETHORPHAN HYDROBROMIDE

Composition:

DEXTROMETHORPHAN HYDROBROMIDE 5 mg in 5 mL

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

- temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold - helps loosen phlegm (mucus) and thin bronchial secretions to drain the bronchial tubes

Authorization status:

OTC monograph final

Summary of Product characteristics

SANATOS CHILDRENS MUCUS RELIEF COUGH- DEXTROMETHORPHAN
HYDROBROMIDE AND GUAIFENESIN LIQUID
PHARMADEL 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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SANATOS CHILDREN'S MUCUS RELIEF COUGH
DRUG FACTS
ACTIVE INGREDIENTS
(IN EACH 5 ML TEASPOONFUL)
PURPOSE
Dextromethorphan HBr, USP 5 mg
Cough
Suppressant
Guaifenesin, USP 100 mg
Expectorant
USES
temporarily relieves cough due to minor throat and bronchial
irritation as may occur
with a cold
helps loosen phlegm (mucus) and thin bronchial secretions to drain the
bronchial
tubes
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 ID THE CHILD HAS
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
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
Poison Control Center right away.
DIRECTIONS
do not take more than 6 doses in any 24-hour period
AGE
DOSE
Children 6 years to
under 12 years
1-2 teaspoonful s
(tsps) every 4 hours
Children 4 years to
under 6 years
½-1 teaspoonful
(tsp) every 4 hours
Children under 4
years
do not use
OTHER INFORMATION
each teaspoon contains: sodium 3 mg
store between 20-25 C (68-77 F)
do not refrigerate
dosage cup provided
Keep cartoon for full directions for use
INACTIVE INGREDIENTS
Anhydrous citric acid, dextrose, D&C Red #33, FD&C Red #40, flavors,
g