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 Children's Mucus Relief Carton Image
HEALTHY ACCENTS CHILDRENS MUCUS RELIEF 
guaifenesin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-288
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorPURPLE (clear) Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55316-288-261 in 1 CARTON07/10/201306/27/2019
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/10/201306/27/2019
Labeler - DZA Brands LLC (090322194)

Revised: 11/2019
Document Id: bb82685f-c216-4939-8b19-c07215f0c5b9
Set id: e861a244-224d-4c97-8761-450935de8737
Version: 3
Effective Time: 20191118
 
DZA Brands LLC