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NDC 63824-0941-11 Mucinex Childrens 100 mg/1 Details

Mucinex Childrens 100 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 GUAIFENESIN.

MedlinePlus Drug Summary

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: 63824-0941-11
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin

Product Information

NDC	63824-0941
Product ID	63824-941_b7b9e9d5-5109-4299-bdf0-7d3d902cc296
Associated GPIs
GCN Sequence Number	061329
GCN Sequence Number Description	guaifenesin GRAN PACK 100 MG ORAL
HIC3	B3J
HIC3 Description	EXPECTORANTS
GCN	97123
HICL Sequence Number	000271
HICL Sequence Number Description	GUAIFENESIN
Brand/Generic	Brand
Proprietary Name	Mucinex Childrens
Proprietary Name Suffix	Chest Congestion Mini-Melts Bubble Gum
Non-Proprietary Name	Guaifenesin
Product Type	HUMAN OTC DRUG
Dosage Form	GRANULE
Route	ORAL
Active Ingredient Strength	100
Active Ingredient Units	mg/1
Substance Name	GUAIFENESIN
Labeler Name	RB Health (US) LLC
Pharmaceutical Class	Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	n/a

Package

Package Images

NDC 63824-0941-11 (63824094111)

Pricing Information	N/A
NDC Package Code	63824-941-11
Billing NDC	63824094111
Package	12 PACKET in 1 CARTON (63824-941-11) / 1 GRANULE in 1 PACKET
Marketing Start Date	2019-03-31
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 34b15037-20f8-4820-85eb-d80722d26bd1 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each packet)

Guaifenesin 100 mg

Purpose

Expectorant

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

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 a fever, rash, or headache that lasts. These could be signs 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.

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, banana flavor, butylated methacrylate copolymer, carbomer homopolymer type A, carboxymethylcellulose sodium, magnesium stearate, microcrystalline cellulose, povidone, sodium bicarbonate, sorbitol, stearic acid, talc, triethyl citrate, tutti-frutti flavor

Questions?

1-866-682-4639

You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

Dist. by: RB Health (US)

Parsippany, NJ 07054-0224

Made in Germany

PRINCIPAL DISPLAY PANEL - 100 mg Granule Packet Carton

Pediatrician Recommended*

NDC 63824-941-11

Mucinex®

Children's

CHEST CONGESTION

Guaifenesin 100 mg – Expectorant

✓ Relieves Chest Congestion

✓ Breaks up Mucus

Ages

4+

years

Bubble Gum

Flavor

12 GRANULE PACKETS

Principal Display Panel - 100 mg Granule Packet Carton

INGREDIENTS AND APPEARANCE

MUCINEX CHILDRENS CHEST CONGESTION MINI-MELTS BUBBLE GUM

guaifenesin granule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63824-941
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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	PINK	Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63824-941-11	12 in 1 CARTON	03/31/2019	02/25/2024
1		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: b7b9e9d5-5109-4299-bdf0-7d3d902cc296

Set id: 34b15037-20f8-4820-85eb-d80722d26bd1

Version: 2

Effective Time: 20211222

Search by Drug Name or NDC

NDC 63824-0941-11 Mucinex Childrens 100 mg/1 Details

Mucinex Childrens 100 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 63824-0941-11 (63824094111)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 34b15037-20f8-4820-85eb-d80722d26bd1 Details

SPL UNCLASSIFIED SECTION

Active ingredient (in each packet)

Purpose

Uses

Warnings

Ask a doctor before use if you have

Directions

Other information

Inactive ingredients

Questions?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 100 mg Granule Packet Carton

INGREDIENTS AND APPEARANCE

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