Country: United States
Language: English
Source: NLM (National Library of Medicine)
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)
PAI Holdings, LLC
GUAIFENESIN
GUAIFENESIN 100 mg in 5 mL
ORAL
OTC DRUG
Expectorant SUGAR FREE / ALCOHOL FREE Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.
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.
OTC monograph final
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 Read the complete document