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NDC 36800-0668-40 topcare nite time 30; 12.5 mg/30mL; mg/30mL Details

topcare nite time 30; 12.5 mg/30mL; mg/30mL

topcare nite time is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates LLC. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE.

MedlinePlus Drug Summary

Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.

Related Packages: 36800-0668-40
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan

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: 36800-0668-40
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Doxylamine

Product Information

NDC	36800-0668
Product ID	36800-668_ea8231ee-7167-4be8-bb37-f3a11f8fc355
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	topcare nite time
Proprietary Name Suffix	cough
Non-Proprietary Name	Dextromethorphan Hydrobromide, Doxylamine Succinate
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	ORAL
Active Ingredient Strength	30; 12.5
Active Ingredient Units	mg/30mL; mg/30mL
Substance Name	DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Labeler Name	Topco Associates LLC
Pharmaceutical Class	Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2024-12-31

Package

Package Images

NDC 36800-0668-40 (36800066840)

Pricing Information	N/A
NDC Package Code	36800-668-40
Billing NDC	36800066840
Package	355 mL in 1 BOTTLE (36800-668-40)
Marketing Start Date	2012-07-16
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ccb345be-164a-4b07-9a50-2cb18584984b Details

Active ingredients (in each 30 mL)

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Purpose

Cough suppressant

Antihistamine

Uses

temporarily relieves cold symptoms:

•: cough due to minor throat and bronchial irritation
•: runny nose and sneezing

Warnings

Do not use

•: if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

•: glaucoma
•: cough that occurs with too much phlegm (mucus)
•: a breathing problem such as emphysema or chronic bronchitis
•: persistent or chronic cough as occurs with smoking, asthma, or emphysema
•: trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

•: excitability may occur, especially in children
•: may cause marked drowsiness
•: avoid alcoholic drinks
•: be careful when driving a motor vehicle or operating machinery
•: alcohol, sedatives, and tranquilizers may increase drowsiness

Stop use and as a doctor if

cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

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

•: take only as directed
•: only use the dose cup provided
•: do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over	30 mL every 6 hrs
children 4 to under 12 yrs	ask a doctor
children under 4 yrs	do not use

Other information

•: each 30 mL contains: sodium 32 mg
•: store at 20-25°C (68-77°F)

Inactive ingredients

alcohol, anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Questions or comments?

1-888-423-0139

Principal Display Panel

TopCare® health

COMPARE TO VICKS® NYQUIL® COUGH ACTIVE INGREDIENTS

ALL NIGHT COUGH RELIEF

Nite Time Cough

COUGH SUPPRESSANT – DEXTROMETHORPHAN HBr

ANTIHISTAMINE – DOXYLAMINE SUCCINATE

• Cough

• Sneezing

• Runny Nose

ALCOHOL 10%

12 FL OZ (355 mL)

CHERRY FLAVOR

INGREDIENTS AND APPEARANCE

TOPCARE NITE TIME COUGH

dextromethorphan hydrobromide, doxylamine succinate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-668
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg in 30 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	12.5 mg in 30 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color	RED (Dark Red)	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:36800-668-38	296 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/03/2004	11/02/2011
2	NDC:36800-668-40	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/16/2012

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	12/10/2002

Labeler - Topco Associates LLC (006935977)

Revised: 9/2022

Document Id: ea8231ee-7167-4be8-bb37-f3a11f8fc355

Set id: ccb345be-164a-4b07-9a50-2cb18584984b

Version: 8

Effective Time: 20220901