SAFETUSSIN PM- dextromethorphan doxylamine succinate liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Dextromethorphan (UNII: 7355X3ROTS) (Dextromethorphan - UNII:7355X3ROTS), DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)

Available from:

Kramer Laboratories

INN (International Name):

Dextromethorphan

Composition:

Dextromethorphan Hydrobromide 7.5 mg in 5 mL

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

- temporarily relieves cough - runny nose and sneezing - asthma - emphysema - glaucoma - excessive phlegm (mucus) - breathing problem - chronic bronchitis - persistent or chronic cough - cough associated with smoking - trouble urinating due to enlarged prostate gland - a sodium-restricted diet Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

Authorization status:

OTC monograph final

Summary of Product characteristics

SAFETUSSIN PM- DEXTROMETHORPHAN DOXYLAMINE SUCCINATE LIQUID
KRAMER LABORATORIES
----------
_DRUG FACTS_
_ACTIVE_
_INGREDIENTS (IN_
_EACH 5ML TSP)_
_PURPOSE_
Dextromethorphan
HBr, USP 7.5 mg
Cough
Suppressant
Doxylamine
Succinate 3.125
mg
Antihistamine
_USES_
temporarily relieves cough
runny nose and sneezing
_WARNINGS_
DO NOT USE 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. • to make a child sleep.
ASK A DOCTOR BEFORE USE IF YOU HAVE
asthma
emphysema
glaucoma
excessive phlegm (mucus)
breathing problem
chronic bronchitis
persistent or chronic cough
cough associated with smoking
trouble urinating due to enlarged prostate gland
a sodium-restricted diet
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 cough lasts more than 7 days, comes back,
or is
accompanied by fever, rash, or persistent headache. 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 right away.
_DIRECTIONS_
do not take more than 4 doses in any 24-hour period
AGE
DOSE
adults and children
12 years and over
4 teaspoons
every 6
hours
children 4 to 12
years
ask a doctor
children under 4
years
do not use
_OTHER INFORMATION:_
Protect from excessive heat and freezing. Store at 15° - 30° C (59°
- 86° F)
Phenylketonurics: each teaspoon contains phenylalanine 4.2 mg
_SAVE THIS