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NDC 00363-0288-26 childrens chest congestion 100 mg/5mL Details

childrens chest congestion 100 mg/5mL

childrens chest congestion is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreen Company. 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: 00363-0288-26
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin

Product Information

NDC	00363-0288
Product ID	0363-0288_fea8bb8f-e30e-46d6-b8b7-2a81e341e143
Associated GPIs	43200010000910
GCN Sequence Number	022210
GCN Sequence Number Description	guaifenesin LIQUID 100 MG/5ML ORAL
HIC3	B3J
HIC3 Description	EXPECTORANTS
GCN	02512
HICL Sequence Number	000271
HICL Sequence Number Description	GUAIFENESIN
Brand/Generic	Generic
Proprietary Name	childrens chest congestion
Proprietary Name Suffix	n/a
Non-Proprietary Name	Guaifenesin
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	ORAL
Active Ingredient Strength	100
Active Ingredient Units	mg/5mL
Substance Name	GUAIFENESIN
Labeler Name	Walgreen Company
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2023-12-31

Package

Package Images

NDC 00363-0288-26 (00363028826)

Pricing Information	N/A
NDC Package Code	0363-0288-26
Billing NDC	00363028826
Package	1 BOTTLE in 1 CARTON (0363-0288-26) / 118 mL in 1 BOTTLE
Marketing Start Date	2007-08-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL fe1dd37c-9485-40c6-8199-59dcf773399c Details

Active ingredient (in each 5 mL)

Guaifenesin, USP 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 the child has

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

Stop use and ask a doctor if

cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.

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
•: do not use dosing cup with other products
•: mL = milliliter

Age	Dose
children 6 years to under 12 years	5 mL – 10 mL every 4 hours
children 4 years to under 6 years	2.5 mL – 5 mL every 4 hours
children under 4 years	do not use

Other information

•: do not use if printed neckband is broken or missing
•: store at 20-25°C (68-77°F)
•: do not refrigerate
•: dosing cup provided

Inactive ingredients

acesulfame potassium, anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, maltitol solution, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Children’s Mucinex® Chest Congestion active ingredient

children’s Chest Congestion

GUAIFENESIN / EXPECTORANT

ALOHOL FREE

Breaks up the mucus that causes congestion

AGES 4–12 YEARS

GRAPE FLAVOR

4 FL OZ (118 mL)

INGREDIENTS AND APPEARANCE

CHILDRENS CHEST CONGESTION

guaifenesin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0288
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

Ingredient Name	Strength
Inactive Ingredients
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	PURPLE (clear)	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0363-0288-26	1 in 1 CARTON	08/30/2007
1		118 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	08/30/2007

Labeler - Walgreen Company (008965063)

Revised: 10/2017

Document Id: fea8bb8f-e30e-46d6-b8b7-2a81e341e143

Set id: fe1dd37c-9485-40c6-8199-59dcf773399c

Version: 4

Effective Time: 20171021