Childrens mucus relief solution

Active ingredients (in each 5 ml)

Dextromethorphan HBr 5 mg

Guaifenesin 100 mg

Purpose

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 Parkinsons disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your childs prescription drug contains an MAOI, ask a doctor or pharmacist before giving 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 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, D&C red #33, FD&C red #40, flavor, glycerin, maltitol solution, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution, xanthan gum

Ingredients and appearance - Product information

Childrens mucus relief solution- Dextromethorphan hbr, guaifenesin

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 55312-608
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Dextromethorphan hydrobromide ( UNII: 9D2RTI9KYH)( Dextromethorphan - UNII: 7355X3ROTS ) 5 mgin 5 mL
Guaifenesin ( UNII: 495W7451VQ)( Guaifenesin - UNII: 495W7451VQ ) 100 mgin 5 mL

Inactive Ingredients

Ingredient Name Code
Acesulfame potassium ( UNII: 23OV73Q5G9)
D&c red no. 33 ( UNII: 9DBA0SBB0L)
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)
Sorbitol ( UNII: 506T60A25R)
Xanthan gum ( UNII: TTV12P4NEE)
Anhydrous citric acid ( UNII: XF417D3PSL)

Product Characteristics

Color RED (Dark Red) Flavor CHERRY

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part341 USA

Labeler - Western Family Foods Inc( 192166072)

Principal display panel

Childrens Mucus Relief

COUGH

Cough Suppressant Dextromethorphan HBr 5 mg

Expectorant Guaifenesin 100 mg

Cough

Chest Congestion

Loosens Mucus

Alcohol-Free

Gluten Free

Age 4+

CHERRY FLAVOR LIQUID

4 FL OZ (118mL)

Compare to the Active Ingredients of Childrens Mucinex ®Cough