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NDC 41250-0704-34 cough and chest congestion 20; 200 mg/10mL; mg/10mL Details

cough and chest congestion 20; 200 mg/10mL; mg/10mL

cough and chest congestion 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; GUAIFENESIN.

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: 41250-0704-34
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan

Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.

Related Packages: 41250-0704-34
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin

Product Information

NDC	41250-0704
Product ID	41250-704_a59423a3-fe82-4487-91ac-ac29e26e2fdb
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	cough and chest congestion
Proprietary Name Suffix	n/a
Non-Proprietary Name	Dextromethorphan HBr, Guaifenesin
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	ORAL
Active Ingredient Strength	20; 200
Active Ingredient Units	mg/10mL; mg/10mL
Substance Name	DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
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 41250-0704-34 (41250070434)

Pricing Information	N/A
NDC Package Code	41250-704-34
Billing NDC	41250070434
Package	1 BOTTLE in 1 CARTON (41250-704-34) / 237 mL in 1 BOTTLE
Marketing Start Date	2014-07-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 662b6fc6-aef1-4898-9440-9f7d1a55fae4 Details

Active ingredients (in each 10 mL)

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 200 mg

Purposes

Cough suppressant

Expectorant

Uses

•: temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
•: helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

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)
•: cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if

cough lasts for more than 7 days, comes back, 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

•: do not take more than 6 doses in any 24-hour period
•: measure only with dosing cup provided
•: keep dosing cup with product
•: mL = milliliter
•: this adult product is not intended for use in children under 12 years of age

age	dose
adults and children 12 years and over	10 mL every 4 hours
children under 12 years	do not use

Other information

•: Phenylketonurics: Contains Phenylalanine 30 mg per 10 mL
•: store at 20-25°C (68-77°F).
: Do not refrigerate.

Inactive ingredients

aspartame, benzoic acid, flavor, glycerin, hydroxyethyl cellulose, menthol, polyethylene glycol, purified water

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Robitussin® Sugar-Free Cough + Chest Congestion DM active ingredients

ADULT

NON-DROWSY

cough + chest congestion

Cough Suppressant

Dextromethorphan HBr

Expectorant | Guaifenesin

SPECIALLY FORMULATED FOR DIABETICS

Relieves: Coughs | Mucus

Chest Congestion

Dye Free | Sugar Free

Alcohol Free

For Ages 12 & Over

8 FL OZ (237 mL)

INGREDIENTS AND APPEARANCE

COUGH AND CHEST CONGESTION

dextromethorphan hbr, guaifenesin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41250-704
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg in 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg in 10 mL

Ingredient Name	Strength
Inactive Ingredients
ASPARTAME (UNII: Z0H242BBR1)
BENZOIC ACID (UNII: 8SKN0B0MIM)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)
MENTHOL (UNII: L7T10EIP3A)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:41250-704-34	1 in 1 CARTON	07/15/2014
1		237 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	07/15/2014

Labeler - Meijer Distribution Inc (006959555)

Revised: 11/2018

Document Id: a59423a3-fe82-4487-91ac-ac29e26e2fdb

Set id: 662b6fc6-aef1-4898-9440-9f7d1a55fae4

Version: 3

Effective Time: 20181105