Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)
SPIRIT PHARMACEUTICALS,LLC
DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE HYDROCHLORIDE 50 mg
ORAL
OTC DRUG
Nighttime Sleep aid For relief occasional sleeplessness
OTC monograph final
DIPHENHYDRAMINE HYDROCHLORIDE- DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED SPIRIT PHARMACEUTICALS,LLC _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._ ---------- DIPHENHYDRAMINE HYDROCHLORIDE SOFT GELATIN CAPSULES DRUG FACTS ACTIVE INGREDIENTS (IN EACH LIQUICAP) Diphenhydramine HCl 50 mg PURPOS E Nighttime Sleep aid US ES For relief occasional sleeplessness WARNINGS 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 Glaucoma trouble urinating due to enlarged postage gland a breathing problem such as emphysema or chronic bronchitis ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE taking sedatives or tranquilizers. WHEN USING THIS PRODUCT avoid alcoholic drinks STOP USE AND ASK 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 KEEP OUT OF REACH OF CHILDREN. In case of overdose,get medical help or contact a poison control center right away. DIRECTION adults and children 12 years of age and older -1 softgel (50mg) at bedtime if needed; or as directed by doctor INACTIVE INGREDIENTS PEG – 400, Propylene Glycol USP , Gelatin , Sorbitol, FD & C Blue No.1 IH, Purified water PRINCIPAL DISPLAY PANEL - 50 MG SHIPPER LABEL DIPHENHYDRAMINE HYDROCHLORIDE SOFT GELATIN CAPSULES EACH SOFT GELATIN CAPSULE CONTAINS: DIPHENHYDRAMINE HYDROCHLORIDE USP 50 MG LOT NO : MFG DATE : EXP. DATE : NDC NO : 68210-1510-4 QUANTITY : 1000 × 4 CAPSULES GROSS WT. : WARNING: KEEP OUT OF REACH OF CHILDREN STORE AT CONTROLLED ROOM TEMPERATURE OF 59° - 86°F (15° - 30°C) PROTECT FROM LIGHT, MOISTURE AND FREEZING THIS BULK SHIPMENT IS INTENDED FOR FURTHER PACKAGING PROCESS ONLY. CONTENTS SHOULD BE APPROVED, REPACKAGED IMMEDIATELY AN Belgenin tamamını okuyun