Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)
GM Pharmaceuticals, INC
ORAL
OTC DRUG
Cough Suppressant - temporarily relieves: cough due to minor throat and bronchial irritation as may occur with a cold
OTC monograph final
CHILDRENS PEDIACLEAR COUGH- DIPHENHYDRAMINE HYDROCHLORIDE LIQUID GM PHARMACEUTICALS, 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._ ---------- CHILDRENS PEDIACLEAR COUGH CHILDREN’S PEDIACLEAR COUGH NDC 58809-750-50 DRUG FACTS ACTIVE INGREDIENTS (IN EACH 1 ML) Diphenhydramine HCl 6.25 mg PURPOS E Cough Suppressant US ES temporarily relieves: cough due to minor throat and bronchial irritation as may occur with a cold WARNINGS may cause excitability, especially in children DO NOT USE to sedate or make a child sleepy with any other product containing diphenhydramine, even one used on skin ASK A DOCTOR BEFORE USE IF YOUR CHILD HAS glaucoma a breathing problem such as emphysema or chronic bronchitis a cough that lasts or is chronic such as occurs with asthma or if cough is accompanied by excessive phlegm (mucus) Ask a doctor before use if the child is taking sedatives or tranquilizers WHEN USING THIS PRODUCT do not use more than directed may cause marked drowsiness sedatives and tranquilizers may increase drowsiness STOP USE AND ASK A DOCTOR IF: symptoms do not improve within 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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. DIRECTIONS take every 4 hours, or as directed by a doctor do not take more than 6 doses in 24 hours or as directed by a doctor do not give more than directed or exceed the recommended daily dosage use only with enclosed dropper do not use enclosed dropper for any other drug product Children 6 to under 12 years of age: 2 mL (2 dropperfuls) Children under 6 years of age: ask a doctor OTHER INFORMATION store at controlled room temperature 15°-30°C (59°-86°F) Tamper Olvassa el a teljes dokumentumot