SLEEP AID- doxylamine succinate tablet

Drug Labeling and Warnings

Drug Details [pdf]

Active ingredient (in each tablet)

Doxylamine succinate 25 mg

Purpose

Nighttime sleep-aid

Use

• helps to reduce difficulty in falling asleep

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 asthma, emphysema or chronic bronchitis
• glaucoma
• trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking

• a sedative 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 (1-800-222-1222).

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 20-25°C (68-77°F)
• keep carton. It contains important 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

meijer®

Sleep Aid

COMPARE TO UNISOM® SLEEPTABS® ACTIVE INGREDIENT

DOXYLAMINE SUCCINATE TABLETS, 25 mg | NIGHTTIME SLEEP-AID

Clinically Tested, Proven Effective

Helps to Reduce Difficulty In Falling Asleep

1 Tablet Per Dose

96 TABLETS

Actual Size

INGREDIENTS AND APPEARANCE

SLEEP AID 
doxylamine succinate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41250-441
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
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)

Product Characteristics
Color	BLUE	Score	2 pieces
Shape	OVAL	Size	10mm
Flavor		Imprint Code	L441
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41250-441-64	32 in 1 CARTON	02/21/1997	07/01/2018
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 41250-441-01	1 in 1 CARTON	03/05/2026
2	NDC: 41250-441-00	96 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	ANDA040167	02/21/1997

Labeler - Meijer Distribution Inc (006959555)