EZ NITE SLEEP- diphenhydramine hydrochloride solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Kroger Company

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Nighttime sleep-aid taking sedatives or tranquilizers sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

Authorization status:

OTC monograph final

Summary of Product characteristics

EZ NITE SLEEP- DIPHENHYDRAMINE HYDROCHLORIDE SOLUTION
KROGER COMPANY
_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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KROGER CO. EZ NITE SLEEP DRUG FACTS
ACTIVE INGREDIENT (IN EACH 30 ML)
Diphenhydramine HCl 50 mg
PURPOSE
Nighttime sleep-aid
USES
•
•
WARNINGS
DO NOT USE
•
•
ASK A DOCTOR BEFORE USE IF YOU HAVE
•
•
•
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
taking sedatives or tranquilizers
WHEN USING THIS PRODUCT
avoid alcoholic beverages
for the relief of occasional sleeplessness
reduces time to fall asleep if you have difficulty falling asleep
for 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
difficulty in urination due to enlargement of the prostate gland
STOP USE AND ASK A 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 (1-
800-222-1222).
DIRECTIONS
•
•
adults & children 12 yrs & over
30 mL at bed time if needed or as directed by a doctor
children under 12 yrs
do not use
OTHER INFORMATION
•
•
INACTIVE INGREDIENTS
alcohol, anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor,
high fructose corn
syrup, poloxamer 407, propylene glycol, purified water, saccharin
sodium, sodium
benzoate, sodium citrate
QUESTIONS?
1-800-632-6900
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
COMPARE TO the active ingredient of VICKS ZZZQUIL
See back panel
Kroger
Nighttime Sleep-Aid
EZ Nite Sleep
Diphenhydramine HCl 50mg per 30mL
take only one dose per day (24 hours)
only use the dose cup provided
EACH 30 ML CONTAINS: sodium 20 mg
store at 20-25 C (6