SAFETUSSIN PM- dextromethorphan 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:

Denison Pharmaceuticals, LLC.

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Cough Suppressant Antihistamine - temporarily relieves coughgh • runny nose and sneezing 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 serious conditions.

Authorization status:

OTC monograph final

Summary of Product characteristics

SAFETUSSIN PM- DEXTROMETHORPHAN DOXYLAMINE SUCCINATE LIQUID
DENISON PHARMACEUTICALS, 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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SAFETUSSIN PM
ACTIVE INGREDIENT
_ACTIVE INGREDIENTS (IN_
_EACH 5ML TSP)_
_PURPOSE_
Dextromethorphan
HBr,USP 7.5 mg
Cough
Suppressant
Doxylamine Succinate,
USP 3.125 mg
Expectorant
USES
Cough Suppressant
Antihistamine
KEEP OUT OF REACH OF CHILDREN
In case of overdose, get medical help or contact a Poison Control
Center right away
INDICATIONS & USAGE
temporarily relieves coughgh • runny nose and sneezing
DOSAGE & ADMINISTRATION
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
aspartame,benzoic acid,citric
acid,glycerin,menthol,methylparaben,natural peppermint
flavor,propylene
glycol,propylparaben
purified water
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.
ASK A DOCTOR
Before you use if you have:
Asthma
emphysema
glaucoma
excessive phlem (mucus)
breathing problem
chronic bronchitis
persisten or chronic cough
cough associated with smoking
trouble urinating do to enlarged prostate gland
a sodium restricted diet
ASK DOCTOR/PHARMACIST
If you are taking sedatives or tranquilizers.
WHEN USING
do not use more than directed
excitability may occur, specially in children
marked drowsiness may occur
avoid alcoholic drinks
be careful when driing
be careful when driving a motor vehicle or operating machinery
alcohol, sedatives and tranquilizers may increase drowsiness
STOP USE
Ask a doctor if cough lasts more than 7 days, comes bac