NIGHT TIME COUGH- dextromethorphan hydrobromide, doxylamine succinate liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS), DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)

Available from:

Select Brand Dist.

INN (International Name):

DEXTROMETHORPHAN HYDROBROMIDE

Composition:

DEXTROMETHORPHAN HYDROBROMIDE 30 mg in 30 mL

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Cough suppressant Antihistamine temporarily relieves cold symptoms - cough - runny nose and sneezing

Authorization status:

OTC monograph final

Summary of Product characteristics

NIGHT TIME COUGH- DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
LIQUID
SELECT BRAND DIST.
_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 30 ML)
Dextromethorphan HBr 30 mg
Doxylamine succinate 12.5 mg
PURPOS E
Cough suppressant
Antihistamine
US ES
temporarily relieves cold symptoms
cough
runny nose and sneezing
WARNINGS
DO NOT USE
to make a child sleepy
if you are now 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 prescription drug
contains an MAOI, ask a
doctor or pharmacist before taking this product.
ASK A DOCTOR BEFORE USE IF YOU HAVE
a sodium-restricted diet
asthma
emphysema
glaucoma
excessive phlegm (mucus)
breathing problems
chronic bronchitis
persistent or chronic cough
cough associated with smoking
trouble urinating due to enlarged prostate gland
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
taking sedatives or tranquilizers.
WHEN USING THIS PRODUCT
DO NOT USE MORE THAN DIRECTED
excitability may occur, especially in children
marked drowsiness may occur
avoid alcoholic drinks
be careful when driving a motor vehicle or operating machinery
alcohol, sedatives, and tranquilizers may increase drowsiness
STOP USE AND ASK A DOCTOR IF
redness or swelling is present
new symptoms occur
fever gets worse or lasts more than 3 days
pain or cough gets worse or lasts more than 7 days
cough comes back or occurs with rash or headache that lasts
These could be signs of a serious condition.
IF PREGNANT OR BREAST-FEEDING,
ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN.
In case of overdose, get medical help or contact a Poison Control
Center (1-800-222-1222)
immediately.
DIRECTIONS
TAKE ONLY AS RECOMMENDED
do not exce