UNISOM SLEEPTABS- doxylamine succinate tablet

Unisom SleepTabs by

Drug Labeling and Warnings

Unisom SleepTabs by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)         

Doxylamine succinate 25 mg

Purpose

Nighttime sleep-aid

Use   

■ helps to reduce difficulty in falling asleep

Warnings   

See carton for complete warnings 

Do not use

■ in children under 12 years of age

■ with any other product containing doxylamine

■ unless you have time for a full night’s sleep

Ask a doctor before use if you have

■ a breathing problem such as emphysema or chronic bronchitis

■ glaucoma

■ trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are taking

■ sedatives or any other sleep-aid

■ tranquilizers

■ any other antihistamines

■ any other drugs

When using this product

■ avoid alcoholic beverages

■ do not drive a motor vehicle or operate machinery

■ 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

■ TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING  

■ 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 

■ use by expiration date on package 

Inactive Ingredients

dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions or comments?

1-866-844-2798 Monday - Friday 8am-6pm ET

Principal Display Panel

Unisom
SleepTabs
Doxylamine succinate tablets, 25 mg
NIGHTTIME SLEEP-AID

INGREDIENTS AND APPEARANCE

UNISOM SLEEPTABS 
doxylamine succinate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0608
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	25 mg

Inactive Ingredients
Ingredient Name	Strength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	blue (Light Blue)	Score	2 pieces
Shape	OVAL	Size	13mm
Flavor		Imprint Code	Unisom;ST
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0608-4	1 in 1 CARTON	03/16/2026
1		4 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 41167-0608-0	1 in 1 CARTON	03/16/2026
2		16 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 41167-0608-1	1 in 1 CARTON	03/16/2026
3		32 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 41167-0608-2	1 in 1 CARTON	03/16/2026
4		48 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 41167-0608-3	1 in 1 CARTON	03/16/2026
5		80 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040564	03/16/2026

Labeler - Chattem, Inc. (003336013)