GUAIFENESIN liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)

Available from:

Cardinal Health

INN (International Name):

GUAIFENESIN

Composition:

GUAIFENESIN 300 mg in 15 mL

Prescription type:

OTC DRUG

Authorization status:

OTC monograph final

Summary of Product characteristics

GUAIFENESIN- GUAIFENESIN LIQUID
CARDINAL HEALTH
_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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GUAIFENESIN ORAL SOLUTION 300 MG/15 ML
DRUG INFORMATION
Guaifenesin Oral Solution USP
Expectorant
Sugar Free/ Alcohol Free
ACTIVE INGREDIENT
Each 5 mL (1 teaspoonful) contains: Guaifenesin 100 mg
PURPOS E
Expectorant
KEEP OUT OF REACH OF CHILDREN
Keep out of the reach of children. In case of overdose, get medical
help or contact a Poison Control
Center right away.
US ES
Helps loosen phlegm (mucus) and thin bronchial secretions to make
coughs more productive.
WARNINGS
Ask a doctor before use if you have
•
•
Stop use and ask a doctor if
•
•
If pregnant or breast-feeding, ask a health professional before use.
Professional Note: Guaifenesin has been shown to produce a color
interference with certain clinical
laboratory determinations of 5-hydroxyindoleacetic acid (5-HIAA) and
vanillymandelic acid (VMA).
DIRECTIONS
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.
you are hypersensitive to any of the ingredients.
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 to 20 mL (2 to 4 teaspoonfuls) every 4 hours
children 6 years to under 12 years
5 to 10 mL (1 to 2 teaspoonfuls) every 4 hours
children 2 to under 6 years of age
2.5 to 5 mL (1/2 to 1 teaspoonful) every 4 hours
children under 2 years of age
consult a physician
INACTIVE INGREDIENTS
Acesulfame K, citric acid, FD&C Green No. 3, FD&C Red No. 40,
flavoring, hydroxyethylcellulose,
purified water, sodium benzoate and sodium citrate.
Sodium Content: 4 mg