DEXTROMETHORPHAN HYDROBROMIDE capsule, liquid filled

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)

Available from:

ONE2ZEE LIMITED LIABILITY COMPANY

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Cough suppressant temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.

Authorization status:

OTC monograph final

Summary of Product characteristics

DEXTROMETHORPHAN HYDROBROMIDE- DEXTROMETHORPHAN
HYDROBROMIDE CAPSULE, LIQUID FILLED
ONE2ZEE LIMITED LIABILITY COMPANY
_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 INGREDIENT (IN EACH SOFTGEL)_
Dextromethorphan HBr, USP 15mg
_PURPOSE_
Cough suppressant
_USE_
temporarily relieves cough due to minor throat and bronchial
irritation as may occur with
a cold.
_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 USE IF YOU HAVE_
a cough that occurs with too much phlegm (mucus)
a cough that lasts or is chronic as occurs with smoking, asthma, or
emphysema
STOP USE AND ASK DOCTOR IF cough lasts for 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
orcontact a
Poison Control Center right away.
_DIRECTIONS_
do not take more than 8 softgels in any 24-hour period
this adult product is not intended for use in children under 12 years
of age
adults and children 12 years and over take 2 capsules every 6 to 8
hours, as needed
children under 12 years do not use
_OTHER INFORMATION_
store at 20-25°C (68-77°F)
avoid excessive heat above 40°C (104°F)
protect from light
_INACTIVE INGREDIENTS_
polyethylene glycol 400, propylene glycol, povidone k30, fd&c red no.
40, fd&c yellow
no. 6, gelatin, glycerin, sorbitol, water
PRINCIPAL DISPLAY PANEL
DEXTROMETHORPHAN HYDROBROMIDE
dextromethorphan hydrobromide capsule, li