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:

Cardinal Health 107, LLC

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Non-Narcotic, Alcohol Free Expectorant/Cough Suppressant

Authorization status:

OTC monograph final

Summary of Product characteristics

GUAIFENESIN DM- GUAIFENESIN AND DEXTROMETHORPHAN SYRUP
CARDINAL HEALTH 107, LLC
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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
•
•
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
•
•
STOP USE AND ASK A DOCTOR IF
•
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
cough that occurs with too much phlegm (mucus)
cough that lasts or is chronic such as occurs with smoking, asthma,
chronic
bronchitis, or emphysema
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.
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.
•
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)
every 4 hours
children 2 years to
under 6 years
2.5 mL (1/2 teaspoonf