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NDC 63824-0284-64 Childrens Mucinex Stuffy Nose and Cold 100; 2.5 mg/5mL; mg/5mL Details

Childrens Mucinex Stuffy Nose and Cold 100; 2.5 mg/5mL; mg/5mL

Childrens Mucinex Stuffy Nose and Cold is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by RB Health (US) LLC. The primary component is GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE.

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: 63824-0284-64
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin

Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.

Related Packages: 63824-0284-64
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Phenylephrine

Product Information

NDC	63824-0284
Product ID	63824-284_61dc7407-eefc-41a3-8c90-75a864a67626
Associated GPIs	43996202100915
GCN Sequence Number	063318
GCN Sequence Number Description	guaifenesin/phenylephrine HCl LIQUID 100-2.5/5 ORAL
HIC3	B4W
HIC3 Description	DECONGESTANT-EXPECTORANT COMBINATIONS
GCN	99069
HICL Sequence Number	000250
HICL Sequence Number Description	GUAIFENESIN/PHENYLEPHRINE HCL
Brand/Generic	Brand
Proprietary Name	Childrens Mucinex Stuffy Nose and Cold
Proprietary Name Suffix	n/a
Non-Proprietary Name	Guaifenesin and Phenylephrine Hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	ORAL
Active Ingredient Strength	100; 2.5
Active Ingredient Units	mg/5mL; mg/5mL
Substance Name	GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Labeler Name	RB Health (US) LLC
Pharmaceutical Class	Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	n/a

Package

Package Images

NDC 63824-0284-64 (63824028464)

Pricing Information	N/A
NDC Package Code	63824-284-64
Billing NDC	63824028464
Package	1 BOTTLE in 1 CARTON (63824-284-64) / 118 mL in 1 BOTTLE
Marketing Start Date	2012-07-13
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 8d0f2a01-f58b-43c0-b3f6-a88f9eb39c52 Details

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients (in each 5 mL)	Purposes
Guaifenesin 100 mg	Expectorant
Phenylephrine HCl 2.5 mg	Nasal decongestant

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
temporarily relieves:
- nasal congestion due to a cold
- stuffy nose

Warnings

Do not use in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if the child has

heart disease
high blood pressure
thyroid disease
diabetes
cough that occurs with too much phlegm (mucus)
persistent or chronic cough such as occurs with asthma

When using this product do not use more than directed

Stop use and ask a doctor if

your child gets nervous, dizzy or sleepless
symptoms do not get better within 7 days or occur with fever
cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

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

Directions

do not take more than 6 doses in any 24-hour period
measure only with dosing cup provided
do not use dosing cup with other products
mL = milliliter

Age	Dose
children 6 years to under 12 years	10 mL every 4 hours
children 4 years to under 6 years	5 mL every 4 hours
children under 4 years	do not use

Other information

each 5 mL contains: sodium 3 mg
tamper evident: do not use if neckband on bottle cap is broken or missing
store between 20-25°C (68-77°F)
do not refrigerate
dosing cup provided

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate1, xanthan gum

1: may contain this ingredient

Questions?

1-866-MUCINEX (1-866-682-4639)

You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

Dist. by: Reckitt Benckiser, Parsippany, NJ 07054-0224

Made in England

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

NDC 63824-284-64

Children's

Mucinex®

Stuffy Nose &

Cold

Expectorant

Nasal Decongestant

Guaifenesin 100 mg

Phenylephrine HCl 2.5 mg

✓: Stuffy Nose
✓: Chest Congestion
✓: Breaks up Mucus

Age 4+

Mixed Berry

Flavor Liquid

4 FL OZ

(118 mL)

Principal Display Panel - 118 mL Bottle Carton

INGREDIENTS AND APPEARANCE

CHILDRENS MUCINEX STUFFY NOSE AND COLD

guaifenesin and phenylephrine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63824-284
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)	Guaifenesin	100 mg in 5 mL
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV)	Phenylephrine Hydrochloride	2.5 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
anhydrous citric acid (UNII: XF417D3PSL)
edetate disodium (UNII: 7FLD91C86K)
FD&C red no. 40 (UNII: WZB9127XOA)
glycerin (UNII: PDC6A3C0OX)
propylene glycol (UNII: 6DC9Q167V3)
propyl gallate (UNII: 8D4SNN7V92)
water (UNII: 059QF0KO0R)
sodium benzoate (UNII: OJ245FE5EU)
sorbitol (UNII: 506T60A25R)
sucralose (UNII: 96K6UQ3ZD4)
trisodium citrate dihydrate (UNII: B22547B95K)
xanthan gum (UNII: TTV12P4NEE)

Product Characteristics
Color	PINK	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63824-284-64	1 in 1 CARTON	07/13/2012	02/15/2024
1		118 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	07/13/2012	02/15/2024

Labeler - RB Health (US) LLC (081049410)

Revised: 2/2022

Document Id: 61dc7407-eefc-41a3-8c90-75a864a67626

Set id: 8d0f2a01-f58b-43c0-b3f6-a88f9eb39c52

Version: 4

Effective Time: 20220225

Search by Drug Name or NDC

NDC 63824-0284-64 Childrens Mucinex Stuffy Nose and Cold 100; 2.5 mg/5mL; mg/5mL Details

Childrens Mucinex Stuffy Nose and Cold 100; 2.5 mg/5mL; mg/5mL

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 63824-0284-64 (63824028464)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 8d0f2a01-f58b-43c0-b3f6-a88f9eb39c52 Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Uses

Warnings

Ask a doctor before use if the child has

Directions

Other information

Inactive ingredients

Questions?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

INGREDIENTS AND APPEARANCE

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