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NDC 00363-0441-01 WAL SOM 25 mg/1 Details

WAL SOM 25 mg/1

WAL SOM is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreen Company. The primary component is DOXYLAMINE SUCCINATE.

MedlinePlus Drug Summary

Doxylamine is used in the short-term treatment of insomnia (difficulty falling asleep or staying asleep). Doxylamine is also used in combination with decongestants and other medications to relieve sneezing, runny nose, and nasal congestion caused by the common cold. Doxylamine should not be used to cause sleepiness in children. Doxylamine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Related Packages: 00363-0441-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Doxylamine

Product Information

NDC	00363-0441
Product ID	0363-0441_9cfe1589-c9d7-4076-be2c-27bcbd754b09
Associated GPIs	60300010100310
GCN Sequence Number	003707
GCN Sequence Number Description	doxylamine succinate TABLET 25 MG ORAL
HIC3	H2E
HIC3 Description	SEDATIVE-HYPNOTICS,NON-BARBITURATE
GCN	11730
HICL Sequence Number	004482
HICL Sequence Number Description	DOXYLAMINE SUCCINATE
Brand/Generic	Generic
Proprietary Name	WAL SOM
Proprietary Name Suffix	NIGHTTIME SLEEP AID
Non-Proprietary Name	Doxylamine succinate
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	25
Active Ingredient Units	mg/1
Substance Name	DOXYLAMINE SUCCINATE
Labeler Name	Walgreen Company
Pharmaceutical Class	Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA040167
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00363-0441-01 (00363044101)

Pricing Information	N/A
NDC Package Code	0363-0441-01
Billing NDC	00363044101
Package	1 BOTTLE in 1 CARTON (0363-0441-01) / 96 TABLET in 1 BOTTLE
Marketing Start Date	2012-09-28
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b80da99b-d98d-4ff2-a353-192399b84a01 Details

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 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 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. (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 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

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

Compare to Unisom® Sleep Tabs® active ingredient

NIGHTTIME SLEEP AID

Wal-Som®

DOXYLAMINE SUCCINATE TABLETS, 25 mg / NIGHTTIME SLEEP AID

NIGHTTIME

TABLETS

Clinically tested, proven effective

48 TABLETS

ONE TABLET PER DOSE

ACTUAL SIZE

INGREDIENTS AND APPEARANCE

WAL SOM NIGHTTIME SLEEP AID

doxylamine succinate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0441
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
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0363-0441-67	48 in 1 CARTON	03/05/1999
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:0363-0441-01	1 in 1 CARTON	09/28/2012
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	ANDA040167	03/05/1999

Labeler - Walgreen Company (008965063)

Revised: 7/2020

Document Id: 9cfe1589-c9d7-4076-be2c-27bcbd754b09

Set id: b80da99b-d98d-4ff2-a353-192399b84a01

Version: 5

Effective Time: 20200720