DRKIDS CHILDRENS COUGH AND CHEST CONGESTION DM- dextromethorphan hydrobromide, guaifenesin solution

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:

CalmCo LLC

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 make cough more productive

Authorization status:

OTC monograph final

Summary of Product characteristics

DRKIDS CHILDRENS COUGH AND CHEST CONGESTION DM- DEXTROMETHORPHAN
HYDROBROMIDE, GUAIFENESIN SOLUTION
CALMCO LLC
----------
DRKIDS CHILDREN’S COUGH & CHEST CONGESTION DM
_ACTIVE INGREDIENT (IN EACH 5ML)_
Dextromethorphan HBr, USP, 5mg
Guaifenesin, USP, 100mg
_PURPOSE_
Cough suppressant
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 make
cough more
productive
_WARNINGS_
_DO NOT USE_
if your child is taking a prescription monoamine oxidase inhibitor
(MAOI) (certain drugs
for depression, psychiatric, or emotional conditions, or Parkinson’s
disease), or for two
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 YOUR CHILD HAS_
persistent or chronic cough such as occurs with asthma or if cough is
accompanied by
excessive phlegm (mucus).
_STOP USE AND ASK A DOCTOR IF_
cough lasts for more than 7 days, tends to recur, or is accompanied by
fever, rash, or
persistent headache. A persistent cough may be a sign 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. (1-
800-222-1222)
_DIRECTIONS_
do not give more than 6 doses in any 24 hour period
give the recommended number of vials below, following the instructions
under How to
Open and Use on the side panel
empty all liquid in each Single-Use Vial when dosing
DOSING CHARt
AGE (YEARS)
DOSE
under 4 years
Consult a doctor
4 – 5 years
1 Single-Use Vial (5 mL) every 4 hours
6 – 11 years
1 – 2 Single-Use Vials (5 mL each) every 4 hours
Adults and children 12 years and over 2 – 4 Single-Use Vials (5 mL
each) every 4 hours
_INACTIVE INGREDIENTS_
citric acid, glycerin, mixed berry flavor, propylene glycol, purified
water, sodium
benzoate, sodium saccharin, sorbitol, sucralose, trisodium citrate
dihydrate, xanthan
gum
_OTHE