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NDC 36800-0441-64 TopCare Sleep Aid 25 mg/1 Details

TopCare Sleep Aid 25 mg/1

TopCare Sleep Aid is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates LLC. 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: 36800-0441-64
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Doxylamine

Product Information

NDC	36800-0441
Product ID	36800-441_b31d584d-5d1c-42e4-8326-e02f4ddebbc5
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	TopCare 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	Topco Associates LLC
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

NDC 36800-0441-64 (36800044164)

Pricing Information	N/A
NDC Package Code	36800-441-64
Billing NDC	36800044164
Package	32 BLISTER PACK in 1 CARTON (36800-441-64) / 1 TABLET in 1 BLISTER PACK
Marketing Start Date	1997-01-29
NDC Exclude Flag	N