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NDC 00113-0441-73 Good sense sleep aid 25 mg/1 Details

Good sense sleep aid 25 mg/1

Good sense sleep aid is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by L. Perrigo 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: 00113-0441-73
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Doxylamine

Product Information

NDC	00113-0441
Product ID	0113-0441_109a2834-9fdd-4e6e-bce9-5639acc6b3ed
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	Good sense sleep aid
Proprietary Name Suffix	n/a
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	L. Perrigo 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 00113-0441-73 (00113044173)

Pricing Information
NDC Package Code	0113-0441-73
Billing NDC	00113044173
Package	16 BLISTER PACK in 1 CARTON (0113-0441-73) / 1 TABLET in 1 BLISTER PACK
Marketing Start Date	1997-08-03
NDC Exclude Flag	N
Price Per Unit	0.11506
Pricing Unit	EA
Effective Date	2024-02-21
NDC Description	GS SLEEP AID 25 MG TABLET
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL f0a0eb93-96e0-432b-9b82-f0e891483be0 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 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 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

Nighttime

Sleep Aid Tablets

Doxylamine Succinate Tablets, 25 mg

Nighttime Sleep-Aid

Actual Size

Clinically Tested, Proven Effective

One Tablet Per Dose

Compare to active ingredient of Unisom® SleepTabs®

100% SATISFACTION GUARNATEED

32 Tablets

INGREDIENTS AND APPEARANCE

GOOD SENSE SLEEP AID

doxylamine succinate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0113-0441
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	no score
Shape	OVAL	Size	10mm
Flavor		Imprint Code	L441
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0113-0441-64	32 in 1 CARTON	04/14/1997
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:0113-0441-73	16 in 1 CARTON	08/03/1997
2		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA040167	04/14/1997

Labeler - L. Perrigo Company (006013346)

Revised: 7/2020

Document Id: 109a2834-9fdd-4e6e-bce9-5639acc6b3ed

Set id: f0a0eb93-96e0-432b-9b82-f0e891483be0

Version: 4

Effective Time: 20200720