GUAIFENESIN solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

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:

Expectorant SUGAR FREE / ALCOHOL FREE Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

Product summary:

Guaifenesin Oral Solution USP is a red, raspberry flavored solution supplied in the following oral dosage forms: NDC 0121-0744-04: 4 fl oz (120 mL) bottle NDC 0121-0744-08: 8 fl oz (237 mL) bottle NDC 0121-0744-16: 16 fl oz (473 mL) bottle NDC 0121-1744-05: 5 mL unit dose cup NDC 0121-1744-00: Case contains 100 unit dose cups of 5 mL (0121-1744-05) packaged in 10 trays of 10 unit dose cups each. NDC 0121-1488-10: 10 mL unit dose cup NDC 0121-1488-00: Case contains 100 unit dose cups of 10 mL (0121-1488-10) packaged in 10 trays of 10 unit dose cups each. NDC 0121-2232-15: 15 mL unit dose cup NDC 0121-2232-00: Case contains 100 unit dose cups of 15 mL (0121-2232-15) packaged in 10 trays of 10 unit dose cups each.

Authorization status:

OTC monograph final

Summary of Product characteristics

GUAIFENESIN- GUAIFENESIN SOLUTION
PHARMACEUTICAL ASSOCIATES, 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._
----------
GUAIFENESIN
_Expectorant _
_SUGAR FREE / ALCOHOL FREE_
DESCRIPTION
Each 5 mL (1 teaspoonful) contains:
Guaifenesin 100 mg
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/5 mL
USES
Helps loosen phlegm (mucus) and thin bronchial secretions to make
coughs more
productive.
WARNINGS
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 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
(½ to 1 teaspoonful)
every 4 hours
children under 2 years of age
consult a physician
Guaifenesin Oral Solution USP is a red, raspberry flavored solution
supplied in the
following oral dosage forms:
NDC 01