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NDC 63824-0942-31 Mucinex Childrens 5; 100 mg/1; mg/1 Details

Mucinex Childrens 5; 100 mg/1; mg/1

Mucinex Childrens is a ORAL GRANULE in the HUMAN OTC DRUG category. It is labeled and distributed by RB Health (US) LLC. 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: 63824-0942-31
Last Updated: 12/01/2022
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: 63824-0942-31
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin

Product Information

NDC	63824-0942
Product ID	63824-942_45ab0502-ae94-434f-a8ef-cbcd47732f6b
Associated GPIs
GCN Sequence Number	063317
GCN Sequence Number Description	guaifenesin/dextromethorphan GRAN PACK 100MG-5MG ORAL
HIC3	B3T
HIC3 Description	NON-OPIOID ANTITUSSIVE AND EXPECTORANT COMBINATION
GCN	99068
HICL Sequence Number	000223
HICL Sequence Number Description	GUAIFENESIN/DEXTROMETHORPHAN HBR
Brand/Generic	Brand
Proprietary Name	Mucinex Childrens
Proprietary Name Suffix	Cough Mini-Melts Orange Creme
Non-Proprietary Name	Dextromethorphan Hydrobromide and Guaifenesin
Product Type	HUMAN OTC DRUG
Dosage Form	GRANULE
Route	ORAL
Active Ingredient Strength	5; 100
Active Ingredient Units	mg/1; mg/1
Substance Name	DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Labeler Name	RB Health (US) LLC
Pharmaceutical Class	Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Ant
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	n/a

Package

Package Images

NDC 63824-0942-31 (63824094231)

Pricing Information	N/A
NDC Package Code	63824-942-31
Billing NDC	63824094231
Package	12 PACKET in 1 CARTON (63824-942-31) / 1 GRANULE in 1 PACKET
Marketing Start Date	2019-03-31
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL f572a46a-4852-4b1f-9d4e-e08e432b9ce2 Details

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients (in each packet)	Purposes
Dextromethorphan HBr 5 mg	Cough suppressant
Guaifenesin 100 mg	Expectorant

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
temporarily relieves cough as may occur 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

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

When using this product do not use more than directed

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

If pregnant or breast-feeding, ask a healthcare professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

empty entire contents of packet onto tongue and swallow
for best taste, do not chew granules
do not take more than 6 doses in any 24-hour period
dose as follows or as directed by a doctor

Age	Dose
adults and children 12 years of age and over	2 to 4 packets every 4 hours
children 6 years to under 12 years of age	1 to 2 packets every 4 hours
children 4 years to under 6 years of age	1 packet every 4 hours
children under 4 years of age	do not use

Other information

each packet contains: magnesium 6 mg and sodium 3 mg
phenylketonurics: contains phenylalanine 2 mg per packet
store at 20-25°C (68-77°F)

Inactive ingredients

aspartame, butylated methacrylate copolymer, carbomer homopolymer type A, carboxymethylcellulose sodium, creme flavor, magnesium stearate, microcrystalline cellulose, orange flavor, povidone, sodium bicarbonate, sorbitol, stearic acid, talc, triethyl citrate

Questions?

1-866-682-4639

SPL UNCLASSIFIED SECTION

Dist. by: RB Health (US)

Parsippany, NJ 07054-0224

Made in Germany

PRINCIPAL DISPLAY PANEL - 12 Granule Packet Carton

Pediatrician Recommended*

NDC 63824-942-31

Mucinex®

Children's

COUGH

Dextromethorphan HBr 5 mg – Cough Suppressant

Guaifenesin 100 mg – Expectorant

✓ Controls Cough

✓ Relieves Chest Congestion

✓ Breaks up Mucus

Ages

4+

years

Orange Creme

Flavor

12 GRANULE PACKETS

PRINCIPAL DISPLAY PANEL - 12 Granule Packet Carton

INGREDIENTS AND APPEARANCE

MUCINEX CHILDRENS COUGH MINI-MELTS ORANGE CREME

dextromethorphan hydrobromide and guaifenesin granule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63824-942
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS)	Dextromethorphan Hydrobromide	5 mg
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)	Guaifenesin	100 mg

Ingredient Name	Strength
Inactive Ingredients
ASPARTAME (UNII: Z0H242BBR1)
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SORBITOL (UNII: 506T60A25R)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

Product Characteristics
Color	ORANGE	Score
Shape		Size
Flavor	ORANGE	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63824-942-31	12 in 1 CARTON	03/31/2019	02/25/2024
1		1 in 1 PACKET; Type 0: Not a Combination Product
2	NDC:63824-942-18	18 in 1 CARTON	03/31/2019	02/25/2024
2	NDC:63824-942-02	2 in 1 CARTON
2		1 in 1 PACKET; 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	03/31/2019	02/25/2024

Labeler - RB Health (US) LLC (081049410)

Revised: 12/2021

Document Id: 45ab0502-ae94-434f-a8ef-cbcd47732f6b

Set id: f572a46a-4852-4b1f-9d4e-e08e432b9ce2

Version: 2

Effective Time: 20211222

Search by Drug Name or NDC

NDC 63824-0942-31 Mucinex Childrens 5; 100 mg/1; mg/1 Details

Mucinex Childrens 5; 100 mg/1; mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 63824-0942-31 (63824094231)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL f572a46a-4852-4b1f-9d4e-e08e432b9ce2 Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Uses

Warnings

Ask a doctor before use if you have

Directions

Other information

Inactive ingredients

Questions?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 12 Granule Packet Carton

INGREDIENTS AND APPEARANCE

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