DEXTROMETHORPHAN HBR. AND GUAIFENESIN solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS), GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)

Tilgjengelig fra:

Rising Pharma Holdings, Inc.

Administreringsrute:

ORAL

Resept typen:

OTC DRUG

Indikasjoner:

Cough Suppressant Expectorant •   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 drain bronchial tubes

Produkt oppsummering:

NDC Information - Each 5 mL of Guaifenesin Syrup and Dextromethorphan contains Guaifenesin 100mg and Dextromethorphan Hydrobromide 10mg and is supplied in the following oral dosage forms: NDC 57237-312-05  unit dose cup 5mL NDC 57237-312-51 (100 x 5 mL) unit-dose cups Each 10 mL of Guaifenesin Syrup and Dextromethorphan contains Guaifenesin 200mg and Dextromethorphan Hydrobromide 20mg and is supplied in the following oral dosage forms: NDC 57237-313-01 unit dose cup 10mL NDC 57237-313-18 (80 x 10 mL) unit-dose cups

Autorisasjon status:

OTC monograph final

Preparatomtale

DEXTROMETHORPHAN HBR. AND GUAIFENESIN- DEXTROMETHORPHAN HBR. AND
GUAIFENESIN SOLUTION
RISING PHARMA HOLDINGS, INC.
_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._
----------
_DRUG FACTS_
10 MG-100 MG/5 ML -
_ACTIVE INGREDIENT PER 5 ML_ (1 UNIT DOSE)
Dextromethorphan HBr. 10 mg
Guaifenesin 100 mg
20 MG-200 MG/10 ML -
_ACTIVE INGREDIENT PER 10 ML_ (1 UNIT DOSE)
Dextromethorphan HBr. 20 mg
Guaifenesin 200 mg
_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 drain
bronchial tubes
_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
• cough that occurs with too much phlegm (mucus)
• cough that lasts or is chronic such as occurs with smoking,
asthma, chronic
bronchitis, or emphysema
STOP USE AND ASK A DOCTOR IF cough lasts more than 7 days, comes back,
or is
accompanied by fever, rash, or persistant headache. These could be
signs of a serious
condition.
IF PREGNANT OR BREAST-FEEDING, ASK A HEALTHCARE PROFESSIONAL BEFORE
USE.
KEEP OUT OF REACH OF CHILDREN. In case of accidental overdose, get
medical help or
contact a Poison Control Center right away. (1-800-222-1222)
DIRECTIONS
• do not take more than 6 doses in any 24 hour period
20 MG-200 MG/10 ML
AGE
DOSE
Children under 12 years of age
Do not use
Adults and children over 12
years of age
10 mL (1 unit dose) every 4
hours
10 MG-100 MG/5 ML
AGE
DOSE
Children under 6 years of age
Do not use
Children 6 to under 12 year