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:

H E B

INN (International Name):

DOXYLAMINE SUCCINATE

Composition:

DOXYLAMINE SUCCINATE 25 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Nighttime sleep-aid helps to reduce difficulty in falling asleep

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NIGHTTIME SLEEP-AID- DOXYLAMINE SUCCINATE TABLET
H E B
----------
HEB 44-386-BISECT-DELISTED
_ACTIVE INGREDIENT (IN EACH TABLET)_
Doxylamine succinate 25 mg
_PURPOSE_
Nighttime sleep-aid
_USE_
helps to reduce difficulty in falling asleep
_WARNINGS_
ASK A DOCTOR BEFORE USE IF YOU HAVE
glaucoma
a breathing problem such as asthma, emphysema or chronic bronchitis
trouble urinating due to an enlarged prostate gland
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
taking any other drugs.
WHEN USING THIS PRODUCT
avoid alcoholic beverages
take only at bedtime
STOP USE AND ASK A DOCTOR IF
sleeplessness persists continuously for more than two 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.
In case of overdose, get medical help or contact a Poison Control
Center (1-800-222-1222) right away.
_DIRECTIONS_
adults: take one tablet 30 minutes before going to bed; take once
daily or as directed by a doctor
do not give to children under 12 years of age
_OTHER INFORMATION_
TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS
TORN OR BROKEN
store at controlled room temperature 20º-25ºC (68º-77ºF)
see end flap for expiration date and lot number
_INACTIVE INGREDIENTS_
dicalcium phosphate, FD&C blue #1 aluminum lake, magnesium stearate,
microcrystalline cellulose,
sodium starch glycolate
_QUESTIONS OR COMMENTS?_
CALL 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday
PRINCIPAL DISPLAY PANEL
COMPARE to UNISOM SLEEPTABS
active ingredient*
NDC 37808-986-27
H-E-B
NIGHTTIME
SLEEP-AID
Doxylamine Succinate
25 mg
Nighttime Sleep-Aid
•FALL ASLEEP FAST AND SAFE
•ONE TABLET PER DOSE
•EASY TO SWALLOW
actual size
32 TABLETS
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
*This product is not manufactured or distributed by
Chattem, Inc., owner of the registered trademark
Unisom® SleepTabs
.
50844 ORG051338627
MADE WITH PRIDE AND CARE FO