SLEEP-EZ NIGHTTIME SLEEP AID- diphenhydramine hcl 25 mg tablet, coated

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Safrel Pharmaceuticals, LLC.

Via di somministrazione:

ORAL

Tipo di ricetta:

OTC DRUG

Indicazioni terapeutiche:

Nighttime sleep-aid provides relief of occasional sleeplessness

Stato dell'autorizzazione:

OTC monograph final

Scheda tecnica

SLEEP-EZ NIGHTTIME SLEEP AID- DIPHENHYDRAMINE HCL 25 MG TABLET, COATED
SAFREL 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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SLEEP-EZ NIGHTTIME SLEEP AID
ACTIVE INGREDIENT (IN EACH CAPLET)
Diphenhydramine HCl 25 mg
PURPOSE
Nighttime sleep-aid
USES
provides relief of occasional sleeplessness
WARNINGS
DO NOT USE
for children under 12 years of age
with any other product containing diphenhydramine, even one used on
skin
with other drugs that cause drowsiness such as antihistamines and
nighttime cold/flu
products
ASK A DOCTOR BEFORE USE IF YOU HAVE
a breathing problem such as emphysema or chronic bronchitis
trouble urinating due to an enlarged prostate gland
glaucoma
heart disease
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
taking sedative or tranquilizers or any other sleep-aid
WHEN USING THIS PRODUCT
drowsiness will occur
avoid alcoholic beverages and other drugs that cause drowsiness
excitability may occur, especially in children
alcohol, sedatives and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery
STOP USE AND ASK A DOCTOR IF
sleeplessness persists continuously for more than 2 weeks. Insomnia
may be a
symptom of a serious underlying medical illness.
IF PREGNANT OR BREAST-FEEDING
ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN.
Overdose warning: Taking more than directed can cause serious health
problems. In
case of overdose, get medical help or contact a Poison Control Center
(1-800-222-1222)
right away. Quick medical attention is critical for adults as well as
for children even if you
do not notice any signs or symptoms.
DIRECTIONS
DO NOT TAKE MORE THAN DIRECTED (SEE OVERDOSE WARNING)
ADULTS AND CHILDREN 12 YEARS OF AGE AND OVER: - take 2 caplets at
bedtime if
needed or as directed by a doctor
CHILDREN UNDER 12 YEARS OF AGE: do not use
OTHER I