CHILDRENS MUCUS RELIEF- dextromethorphan hbr, guaifensin liquid

Childrens Mucus Relief by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredients (in each 5 mL)

Dextromethorphan HBr 5 mg

Guaifenesin 100 mg

Purposes

Cough suppressant

Expectorant

Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
• temporarily relieves:
  • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • the intensity of coughing
  • the impulse to cough to help your child get to sleep

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 taking this product.

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 headache that lasts. 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 (1-800-222-1222) right away.

Directions

• do not take more than 6 doses in any 24-hour period
• measure only with dosing cup provided. Do not use any other dosing device.
• keep dosing cup with product
• mL = milliliter
• shake well before using

• age: dose
• children 6 to 12 years: 5-10 mL every 4 hours
• children 4 to 5 years: 2.5-5 mL every 4 hours
• children under 4 years: do not use

Other information

• each 5 mL contains: sodium 2 mg
• store at 20-25ºC (68-77ºF). Do not refrigerate.

Inactive ingredients

anhydrous citric acid, D&C red #33, dextrose, FD&C red #40, flavor, glycerin, methylparaben, potassium sorbate, propylene glycol, propylparaben, purified water, saccharin sodium, sodium hydroxide, sucralose, xanthan gum

Questions or comments?

 Call toll free 1-866-322-2439

Principal Display Panel

Children's Mucus Relief

cough

cough suppressant (Dextromethorphan HBr)

expectorant (Guaifenesin)

controls cough

relieves chest congestion

thins & loosens mucus

for ages 4-11 years

CHERRY FLAVOR

Compare to the active ingredients in Children's Mucinex® Cough*

FL OZ (mL)

*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Children's Mucinex® Cough.

TAMPER EVIDENT:  DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY: DZA BRANDS, LLC

Salisbury, NC 28147 /

Scarborough, ME 04074

Package Label

Healthy Accents Children's Mucus Relief Cough Cherry Liquid

INGREDIENTS AND APPEARANCE

CHILDRENS MUCUS RELIEF 
dextromethorphan hbr, guaifensin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55316-294
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
DEXTROSE (UNII: IY9XDZ35W2)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55316-294-04	1 in 1 BOX	02/29/2016	12/31/2021
1		118 mL in 1 BOTTLE, PLASTIC; 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	02/29/2016	12/31/2021

Labeler - Healthy Accents (DZA Brands, LLC) (090322194)