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NDC 00113-6044-67 good sense sleep aid ultra 25 mg/1 Details

good sense sleep aid ultra 25 mg/1

good sense sleep aid ultra 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: 00113-6044-67
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Doxylamine

Product Information

NDC	00113-6044
Product ID	0113-6044_6907ffd1-39cb-4cc5-9c8a-bd975a5b06bd
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	good sense sleep aid ultra
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 00113-6044-67 (00113604467)

Pricing Information	N/A
NDC Package Code	0113-6044-67
Billing NDC	00113604467
Package	48 BLISTER PACK in 1 CARTON (0113-6044-67) / 1 TABLET in 1 BLISTER PACK
Marketing Start Date	2022-08-06
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 6907ffd1-39cb-4cc5-9c8a-bd975a5b06bd 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

Package/Label Principal Display Panel

GOODSENSE®

Nighttime

Sleep Aid Ultra

Doxylamine Succinate Tablets 25 mg

Actual Size

Nighttime Sleep-Aid

1 Tablet Per Dose

Clinically Tested, Proven Effective

Compare to active ingredient of Vicks® ZzzQuil® Ultra Tablets

48 Tablets

INGREDIENTS AND APPEARANCE

GOOD SENSE SLEEP AID ULTRA

doxylamine succinate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0113-6044
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
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

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:0113-6044-67	48 in 1 CARTON	08/06/2022
1		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	08/06/2022

Labeler - L. Perrigo Company (006013346)

Revised: 8/2022

Document Id: 6907ffd1-39cb-4cc5-9c8a-bd975a5b06bd

Set id: 6907ffd1-39cb-4cc5-9c8a-bd975a5b06bd

Version: 1

Effective Time: 20220809