DIPHENHYDRAMINE HYDROCHLORIDE- 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:

Preferred Pharmaceuticals, Inc.

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:

Authorization status:

OTC monograph final

Summary of Product characteristics

DIPHENHYDRAMINE HYDROCHLORIDE- DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE
PREFERRED 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._
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DIPHENHYDRAMINE HYDROCHLORIDE CAPSULES, USP 25MG AND 50MG
DRUG FACTS
.
ACTIVE INGREDIENT
(IN EACH CAPSULE)
Diphenhydramine HCl 25 mg
Diphenhydramine HCl 50 mg
PURPOS E
Antihistamine
US ES
temporarily relieves these symptoms of hay fever or other upper
respiratory allergies:
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WARNINGS
DO NOT USE with any other product containing diphenhydramine, even one
used on skin
ASK A DOCTOR BEFORE USE IF YOU HAVE
•
•
•
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runny nose
itchy nose or throat
sneezing
itchy, watery eyes
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
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OTHER INFORMATION
Diphenhydramine 25mg
Bottle of 10 - 68788-9697-1
Bottle of 30 - 68788-9697-3
Diphenhydramine 50mg
Bottle of 30 - 68788-9698-3
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INACTIVE INGREDIENTS
benzyl alcohol, butylparaben, D&C red# 28, edible black ink, FD&C blue
#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: QUALITEST PHARMACEUTICALS, INC.
REPACKAGED BY: