País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)
Kramer Novis
GUAIFENESIN
GUAIFENESIN 50 mg in 1 mL
ORAL
OTC DRUG
Expectorant Nasal decongestant • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive • temporarily relieves nasal congestion due to the common cold
OTC monograph final
SUPRESS-PE PEDIATRIC- GUIAFENESIN, PHENYLEPHRINE HCL SOLUTION/ DROPS KRAMER NOVIS _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._ ---------- SUPRESS-PE PEDIATRIC _DRUG FACTS_ _ACTIVE INGREDIENTS (IN EACH 1 ML)_ Guaifenesin, 50 mg Phenylephrine HCl, 2.5 mg _PURPOSE_ Expectorant Nasal decongestant _USES_ • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive • temporarily relieves nasal congestion due to the common cold _WARNINGS_ _DO NOT USE _in a child who is 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 child's prescription drug contains a MAOI, ask a doctor or pharmacist before giving this product. _ASK A DOCTOR BEFORE USE IF THE CHILD HAS_ • heart disease • thyroid disease • high blood pressure • diabetes • cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic such as occurs with asthma WHEN USING THIS PRODUCT DO NOT EXCEED RECOMMENDED DOSAGE STOP USE AND ASK A DOCTOR IF • your child gets nervous, dizzy or sleepless • symptoms do not get better within 7 days or are accompanied by fever • cough last more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be a signs of a serious condition. KEEP OUT OF REACH OF CHILDREN. In case of accidental overdose, get medical help or contact a Poison Control Center right away. _DIRECTIONS_ • do not use more than 6 doses in any 24-hour period • repeat every 4 hours • measure with the dosage device provided. Do not use with any other device AGE DOSE children 2 years to under 6 years of age 1 mL children under 2 years of age Consult a doctor _OTHER INFORMATION_ • Tamper Evident Feature: Leia o documento completo