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NDC 41250-0473-40 daytime cough 15 mg/15mL Details

daytime cough 15 mg/15mL

daytime cough is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Meijer Distribution Inc. The primary component is DEXTROMETHORPHAN HYDROBROMIDE.

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: 41250-0473-40
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan

Product Information

NDC	41250-0473
Product ID	41250-473_b3346ecd-5837-4d1c-aa9b-70ed7402d5a5
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	daytime cough
Proprietary Name Suffix	non drowsy
Non-Proprietary Name	dextromethorphan hydrobromide
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	ORAL
Active Ingredient Strength	15
Active Ingredient Units	mg/15mL
Substance Name	DEXTROMETHORPHAN HYDROBROMIDE
Labeler Name	Meijer Distribution Inc
Pharmaceutical Class	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 41250-0473-40 (41250047340)

Pricing Information	N/A
NDC Package Code	41250-473-40
Billing NDC	41250047340
Package	355 mL in 1 BOTTLE (41250-473-40)
Marketing Start Date	2012-12-12
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 754c97e5-8ccd-45a7-946b-a258c09c083d Details

Active ingredient (in each 15 mL)

Dextromethorphan HBr 15 mg

Purpose

Cough suppressant

Use

temporarily relieves cough due to minor throat and bronchial irritation associated with a cold

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

•: cough that occurs with too much phlegm (mucus)
•: persistent or chronic cough such as occurs with smoking, asthma, or emphysema

Stop use and ask 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
•: use dose cup
•: do not exceed 4 doses per 24 hours

adults and children 12 years and over	30 mL every 6-8 hours
children 6 to under 12 years	15 mL every 6-8 hours
children 4 to under 6 years	ask a doctor
children under 4 years	do not use

Other information

•: each 15 mL contains: sodium 13 mg
•: store at 20-25°C (68-77°F)
•: does not meet USP requirements for light resistant packaging

Inactive ingredients

anhydrous citric acid, D&C yellow #10, FD&C yellow #6, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Vicks® DayQuil® Cough active ingredient

NON – DROWSY

daytime cough

Dextromethorphan HBr

Cough Suppressant

All Day Cough Relief

Citrus Blend Flavor

Alcohol Free

Antihistamine Free

Powerful Cough Relief for up to 8 hours

12 FL OZ (355 mL)

INGREDIENTS AND APPEARANCE

DAYTIME COUGH NON DROWSY

dextromethorphan hydrobromide solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41250-473
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg in 15 mL

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)

Product Characteristics
Color	ORANGE (light)	Score
Shape		Size
Flavor	CITRUS (blend)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41250-473-38	296 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/15/2007	07/13/2014
2	NDC:41250-473-40	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/12/2012

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	08/15/2007

Labeler - Meijer Distribution Inc (006959555)

Revised: 11/2021

Document Id: b3346ecd-5837-4d1c-aa9b-70ed7402d5a5

Set id: 754c97e5-8ccd-45a7-946b-a258c09c083d

Version: 7

Effective Time: 20211103