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

Ask a doctor before use if you have

a breathing problem such as asthma, emphysema or chronic bronchitis
difficulty in urination due to enlargement of the prostate gland
glaucoma

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 right away.

Directions

adults and children 12 years and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor
children under 12 years: do not use

Other information

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
store at controlled room temperature 20°-25°C (68°-77°F)
see end flap for expiration date and lot number

Inactive ingredients

dibasic calcium phosphate dihydrate, 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

NDC 11822-9386-6

Compare to the active ingredient in Unisom® SleepTabs®*

SLEEP-AID
DOXYLAMINE SUCCINATE 25 mg
nighttime sleep-aid
helps to reduce difficulty falling asleep

ACTUAL SIZE

48
TABLETS
ONE TABLET PER DOSE

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 REV1120C38622

DISTRIBUTED BY: RITE AID
30 HUNTER LANE,
CAMP HILL, PA 17011
www.riteaid.com

SATISFACTION GUARANTEED
If you're not satisfied, we'll
happily refund your money.

Rite Aid 44-386

SLEEP AID
doxylamine succinate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11822-9386
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
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 POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	blue	Score	no score
Shape	OVAL	Size	10mm
Flavor		Imprint Code	44;386
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11822-9386-2	3 in 1 CARTON	07/30/2019	09/21/2024
1		16 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:11822-9386-6	1 in 1 CARTON	07/30/2019	09/21/2024
2		96 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA040564	07/30/2019	09/21/2024

Labeler - Rite Aid Corporation (014578892)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(11822-9386)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	manufacture(11822-9386) , pack(11822-9386)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(11822-9386)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		117025878	manufacture(11822-9386)

Rite Aid 44-386 Delisted