Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)
GM Pharmaceuticals, Inc.
ORAL
OTC DRUG
Nighttime Sleep-Aid - for the relief of occasional sleeplessnes - reduces time to fall asleep if you have difficulty falling asleep - breathing problems such as emphysema or chronic bronchitis - glaucoma - difficulty in urination due to enlargement of the prostate gland - taking sedatives or tranquilizers Stop use and ask a doctor if - sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
OTC monograph final
TEXACLEAR NIGHTTIME SLEEP-AID- DIPHENHYDRAMINE HCL 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._ ---------- TEXACLEAR NIGHTTIME SLEEP-AID ACTIVE INGREDIENTS (IN EACH 30 ML ) Diphenhydramine HCl 50 mg PURPOSE Nighttime Sleep-Aid USES for the relief of occasional sleeplessnes reduces time to fall asleep if you have difficulty falling asleep WARNINGS DO NOT EXCEED RECOMMENDED DOSAGE. DO NOT USE for children under 12 years of age with any other product containing diphenhydramine, even one used on skin ASK A DOCTOR BEFORE USE IF YOU HAVE breathing problems such as emphysema or chronic bronchitis glaucoma difficulty in urination due to enlargement of the prostate gland ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE taking sedatives or tranquilizers WHEN USING THIS PRODUCT avoid alcoholic beverages drowsiness will occur do not drive a motor vehicle or operate machinery STOP USE AND ASK A DOCTOR IF sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. IF PREGNANT OR BREAST-FEEDING,ask a health professional before use. DIRECTIONS TAKE ONLY 1 DOSE PER DAY (24-HOUR PERIOD). DO NOT EXCEED RECOMMENDED DOSAGE. only use with enclosed dose cup mL = mililiter Adults and children 12 years of age and over: 30 mL at bedtime if needed or as directed by a doctor Children under12 years of age: Do not use. OTHER INFORMATION each 30 mL contains: Sodium 15 mg store at room temperature 20-30ºC INACTIVE INGREDIENTS citric acid anhydrous, glycerin, proplylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol QUESTIONS OR COMMENTS? Call 1-888-535-0305 9 a.m. - 5 p.m. CST. In case of overdose, get medical help or contact a Poison Control Center right away. NDC 58809-116-08 TEXACLEAR NIGHTTIME SLEEP-AID 8 fl oz (237mL) TEXACLEAR NIGHTTIME SLEEP-AI Прочетете целия документ