GUAIFENESIN DM- guaifenesin and dextromethorphan syrup

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

PAI Holdings, LLC

INN (International Name):

GUAIFENESIN

Composition:

GUAIFENESIN 100 mg in 5 mL

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Non-Narcotic, Alcohol Free Expectorant/Cough Suppressant - helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive - temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold

Product summary:

HOW SUPPLIED:  Guaifenesin Syrup and Dextromethorphan is a red, cherry flavored syrup supplied in the following oral dosage forms: NDC 0121-0638-04:  4 fl oz (118 mL) bottle NDC 0121-0638-08:  8 fl oz (237 mL) bottle NDC 0121-0638-16:  16 fl oz (473 mL) bottle NDC 0121­0638-05:  5 mL unit dose cup NDC 0121-0638-00:  Case contains 100 unit dose cups of 5 mL (0121-0638-05) packaged in 10 trays of 10 unit dose cups each. NDC 0121-1276-10:  10 mL unit dose cup NDC 0121-1276-00:  Case contains 100 unit dose cups of 10 mL (0121-1276-10) packaged in 10 trays of 10 unit dose cups each.

Authorization status:

OTC monograph final

Summary of Product characteristics

GUAIFENESIN DM- GUAIFENESIN AND DEXTROMETHORPHAN SYRUP
PAI HOLDINGS, LLC
----------
GUAIFENESIN DM
_Non-Narcotic, Alcohol Free _
_Expectorant/Cough Suppressant_
DESCRIPTION
Each 5 mL (1 teaspoonful) contains:
Guaifenesin
100 mg
Dextromethorphan Hydrobromide 10 mg
_Inactive Ingredients:_ Citric acid, FD&C Red No. 40, flavoring,
glycerin, menthol, purified
water, sodium benzoate, sodium citrate, sodium saccharin, and sucrose.
_Sodium Content:_ 4 mg/5 mL
USES
helps loosen phlegm (mucus) and thin bronchial secretions to make
coughs more
productive
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
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
persistent headache. These could be signs of a serious condition.
you are hypersensitive to any of the ingredients.
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.
PROFESSIONAL NOTE: Guaifenesin has been shown to produce a color
interference with
certain clinical laboratory determinations of 5-hydroxyindoleacetic
acid (5-HIAA) and
vanillylmandelic acid (VMA).
DIRECTIONS: Follow dosage below or use as directed by a physician.
do not take more than 6 doses in any 24-hour period.
AGE
DOSE
adults and children
12 years and over
10 mL (2 teaspoonfuls)
every 4 hours
children 6 years to
under 12 years
5 mL (1 teaspoonful)
e