DZA Brands, LLC Children’s Mucus Relief Drug Facts

Healthy Accents Childrens Mucus Relief by

Drug Labeling and Warnings

Healthy Accents Childrens Mucus Relief by is a Otc medication manufactured, distributed, or labeled by DZA Brands LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HEALTHY ACCENTS CHILDRENS MUCUS RELIEF- guaifenesin solution 
DZA Brands LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DZA Brands, LLC Children’s Mucus Relief Drug Facts

Active ingredient (in each 5 mL)

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 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?

1-866-322-2439

Principal Display Panel

Children’s

mucus relief

guaifenesin 100mg expectorant

chest congestion

breaks up mucus

Compare to Children’s Mucinex® Chest Congestion active ingredient

grape flavor

dosage cup included

age 4+

alcohol free

gluten free

4 FL OZ (118mL)

HEALTHY ACCENTS CHILDRENS MUCUS RELIEF 
guaifenesin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55316-288
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55316-288-26	1 in 1 CARTON	07/10/2013	06/27/2019
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/10/2013	06/27/2019

Labeler - DZA Brands LLC (090322194)

Revised: 11/2019

Document Id: bb82685f-c216-4939-8b19-c07215f0c5b9

34390-5

Set id: e861a244-224d-4c97-8761-450935de8737

Version: 3

Effective Time: 20191118

 

DZA Brands LLC