G
Dosage Form: tablet
Perrigo Sleep Aid Tablets Drug Facts
Active ingredient (in each tablet)
Doxylamine succinate 25 mg
Purpose
Nighttime sleep-aid
Uses
helps to reduce difficulty in falling asleep
Warnings
Ask a doctor before use if you have
a breathing problem such as asthma, emphysema or chronic bronchitis
glaucoma
trouble urinating due to an enlarged prostate gland
Do not give
to children under 12 years of age
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 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.
Directions
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
Other information
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
Inactive ingredients
dibasic calcium phosphate, FD&C blue no. 1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate
Questions or comments?
1-800-719-9260
Principal Display Panel
Fall Asleep Fast!
Sleep Aid Tablets
Doxylamine Succinate Tablets, 25 mg
Nighttime Sleep-Aid
Safe, Proven Effective
Just One Tablet Per Dose
Actual Size
Compare to active ingredient of Unisom® SleepTabs®
Sleep Aid Tablets Carton
Good Sense Sleep Aid
doxylamine succinate tablet
Product Information
Product Type
HUMAN OTC DRUG
NDC Product Code (Source)
0113-0441
Route of Administration
ORAL
DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name
Basis of Strength
Strength
DOXYLAMINE SUCCINATE (DOXYLAMINE)
DOXYLAMINE SUCCINATE
25 mg
Inactive Ingredients
Ingredient Name
Strength
No Inactive Ingredients Found
Product Characteristics
Color
BLUE
Score
no score
Shape
OVAL
Size
10mm
Flavor
Imprint Code
L441
Contains
Packaging
#
NDC
Package Description
Multilevel Packaging
1
0113-0441-64
2 BLISTER PACK In 1 CARTON
contains a BLISTER PACK
1
16 TABLET In 1 BLISTER PACK
This package is contained within the CARTON (0113-0441-64)
2
0113-0441-73
1 BLISTER PACK In 1 CARTON
contains a BLISTER PACK
2
16 TABLET In 1 BLISTER PACK
This package is contained within the CARTON (0113-0441-73)
Marketing Information
Marketing Category
Application Number or Monograph Citation
Marketing Start Date
Marketing End Date
ANDA
ANDA040167
04/14/1997
Labeler - L Perrigo Company (006013346)
Revised: 06/2009L Perrigo Company
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