NIGHTTIME SLEEP AID doxylamine succinate tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)

Available from:

HyVee Inc

INN (International Name):

DOXYLAMINE SUCCINATE

Composition:

DOXYLAMINE SUCCINATE 25 mg

Prescription type:

OTC DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NIGHTTIME SLEEP AID- DOXYLAMINE SUCCINATE TABLET
HYVEE INC
----------
HY-VEE, INC. NIGHTTIME SLEEP AID DRUG FACTS
ACTIVE INGREDIENT (IN EACH TABLET)
Doxylamine succinate 25 mg
PURPOS E
Nighttime sleep-aid
US E
•
WARNINGS
DO NOT USE
in children under 12 years of age
ASK A DOCTOR BEFORE USE IF YOU HAVE
•
•
•
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
taking any other drugs
WHEN USING THIS PRODUCT
•
•
STOP USE AND ASK A DOCTOR IF
•
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
helps to reduce difficulty in falling asleep
a breathing problem such as asthma, emphysema or chronic bronchitis
glaucoma
trouble urinating due to an enlarged prostate gland
avoid alcoholic beverages
take only at bedtime
sleeplessness persists continuously for more than two weeks. Insomnia
may be a symptom of
serious underlying medical illness.
•
•
OTHER INFORMATION
•
•
•
INACTIVE INGREDIENTS
anhydrous dibasic calcium phosphate, dibasic calcium phosphate
dihydrate, FD&C blue no. 1 aluminum
lake, magnesium stearate, microcrystalline cellulose, sodium starch
glycolate
QUESTIONS OR COMMENTS?
1-800-719-9260
PRINCIPAL DISPLAY PANEL
COMPARE TO the Active Ingredient of Unisom® SleepTabs®
Nighttime Sleep Aid
Doxylamine Succinate Tablets, 25 mg
Nighttime Sleep Aid
Clinically Tested, Proven Effective
ACTUAL SIZE
One Tablet Per Dose
16 TABLETS
adults and children 12 years of age and over: take one tablet 30
minutes before going to bed; take
once daily or as directed by a doctor
children under 12 years of age: do not use
store at 68°-77°F (20°-25°C)
retain in carton until time of use
see carton end panel for lot number and expiration date
NIGHTTIME SLEEP AID
doxylamine succinate tablet
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:4250 7-0 33
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF S