DIPHENHYDRAMINE HYDROCHLORIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)

Available from:

Aventura Pharmaceuticals, LLC

INN (International Name):

DIPHENHYDRAMINE HYDROCHLORIDE

Composition:

DIPHENHYDRAMINE HYDROCHLORIDE 25 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antihistamine temporarily relieves these symptoms of hay fever or other upper respiratory allergies: - runny nose - itchy nose or throat - sneezing - itchy, watery eyes

Authorization status:

OTC monograph final

Summary of Product characteristics

DIPHENHYDRAMINE HYDROCHLORIDE- DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE
AVENTURA 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._
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DIPHENHYDRAMINE HYDROCHLORIDE CAPSULES, USP 25MG
DRUG FACTS
.
ACTIVE INGREDIENT
(IN EACH CAPSULE)
Diphenhydramine HCl 25 mg
PURPOS E
Antihistamine
US ES
temporarily relieves these symptoms of hay fever or other upper
respiratory allergies:
runny nose
itchy nose or throat
sneezing
itchy, watery eyes
WARNINGS
DO NOT USE with any other product containing diphenhydramine, even one
used on skin
ASK A DOCTOR BEFORE USE IF YOU HAVE
glaucoma
trouble urinating due to an enlarged prostate 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
you may get very drowsy
avoid alcoholic drinks
alcohol, sedatives & tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery
excitability may occur, especially in children
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
ADULTS AND CHILDREN 12 YEARS AND OVER: take 1 to 2 capsules every 4-6
hours; not more than 6 doses
in 24 hours
CHILDREN UNDER 12 YEARS: ask a doctor
OTHER INFORMATION
store at 15-30 °C (59-86 °F)
protect from moisture
INACTIVE INGREDIENTS
benzyl alcohol, butylparaben, D&C red# 28, edible black ink, FD&C bule
#1, FD&C red# 40, gelatin,
lactose, magnesium stearate, methylparaben, polysorbate 80,
propylparaben, sodium laurel sulfate
QUESTIONS OR COMMENTS
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP OR BAND
AROUND ANY CAPSULE IS MISSING OR DAMAGED
DISTRIBUTED BY: AVENTURA PHARMACEUTICALS, LLC
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DIPHENHY