DORMIN- diphenhydramine hydrochloride capsule

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

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Ficha técnica Ficha técnica (SPC)
12-04-2019

Ingredientes activos:

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

Disponible desde:

Randob Labs,Ltd.

Vía de administración:

ORAL

tipo de receta:

OTC DRUG

Estado de Autorización:

OTC monograph final

Ficha técnica

                                DORMIN- DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE
RANDOB LABS,LTD.
_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._
----------
DRUG FACTS
ACTIVE INGREDIENT
Diphenhydramine Hydrochloride
PURPOS E
KEEP OUT OF REACH OF CHILDREN
KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help
or contact a Poison Control
Center right away.
US ES
▪
WARNINGS
▪
▪
▪
ASK DOCTOR
AS A DOCTOR BEFORE USE IF YOU HAVE
▪
▪
▪
ASK DOCTOR/PHARMACIST
AS A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE taking sedatives or
tranquilizers
WHEN USING
WHEN USING THIS PRODUCT
▪
STOP USE
STOP USE AND ASK A DOCTOR IF sleeplessness lasts for more than 2
weeks. Insomnia may be a symptom of
serious underlying medical illness.
helps to reduce difficulty falling asleep
DO NOT USE
in children under 12 years of age
with any other product containing diphenhydramine, even one used on
skin
a breathing problem such as emphysema or chronic bronchitis
glaucoma
trouble urinating due to enlarged prostate gland
avoid alcoholic drinks
PREGNANCY OR BREAST FEEDING
IF PREGNANT OR BREAST-FEEDING, ask a health professional before use.
DIRECTIONS
Adult and children 12 years and over: Take 2 capsules (50 mg) at
bedtime if needed or as directed by a
doctor
Children under 12 years of age: Do not give this product to children
under 12 years of age
OTHER INFORMATION
▪
Use by expiration date on pack
INACTIVE INGREDIENTS
FD&C Red No. 3, Gelatin, Lactose, Magnesium Stearate, Polyethylene
Glycol, Silicon Dioxide, Talc.
PRINCIPAL DISPLAY PANEL
Dormin®
THE NIGHTTIME SLEEP-AID
With Diphenhydramine Hydrochloride
•
•
•
72 Capsules
DORMIN
diphenhydramine hydrochloride capsule
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:52412-10 0
ROUTE OF ADMINISTRATION
ORAL
keep in dry place
FAST
SAFE
EFFECTIVE
Randob Labs,Ltd.
ROUTE OF ADMINISTRATION
ACTIVE INGREDIENT/ACTIVE MOIETY
INGRED
                                
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