Equaline childrens mucus relief solution

Active ingredients (in each 5 ml)

Dextromethorphan HBr 5 mg

Guaifenesin 100 mg

Phenylephrine HCl 2.5 mg

Purposes

Cough suppressant

Expectorant

Nasal decongestant

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
  • nasal congestion due to a cold
  • stuffy nose

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

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with asthma

When using this product

do not use more than directed

Stop use and ask a doctor if

  • your child gets nervous, dizzy or sleepless
  • symptoms do not get better within 7 days or occur with fever
  • 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
  • dose as follows or as directed by a doctor
  • mL = milliliter

Age

Dose

children 6 years to under 12 years

10 mL every 4 hours

children 4 years to under 6 years

5 mL every 4 hours

children under 4 years

do not use

Other information

  • each 5 mL contains:sodium 3 mg
  • 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

anhydrous citric acid, edetate disodium, FD&C red #40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum

Questions or comments?

1-877-932-7948

Ingredients and appearance - Product information

Equaline childrens mucus relief solution- Dextromethorphan hbr, guaifenesin, phenylephrine hcl

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 41163-839
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
Phenylephrine hydrochloride ( UNII: 04JA59TNSJ)( Phenylephrine - UNII: 1WS297W6MV ) 2.5 mgin 5 mL

Inactive Ingredients

Ingredient Name Code
Anhydrous citric acid ( UNII: XF417D3PSL)
Edetate disodium ( UNII: 7FLD91C86K)
Fd&c red no. 40 ( UNII: WZB9127XOA)
Glycerin ( UNII: PDC6A3C0OX)
Propylene glycol ( UNII: 6DC9Q167V3)
Water ( UNII: 059QF0KO0R)
Sodium benzoate ( UNII: OJ245FE5EU)
Sodium citrate, unspecified form ( UNII: 1Q73Q2JULR)
Sorbitol ( UNII: 506T60A25R)
Sucralose ( UNII: 96K6UQ3ZD4)
Xanthan gum ( UNII: TTV12P4NEE)

Product Characteristics

Color RED (clear) Flavor BERRY

Marketing Information

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

Labeler - Supervalu Inc( 006961411)

Package/label principal display panel

compare to Childrens Mucinex ®Multi-Symptom Cold active ingredients

childrens

mucus relief

guaifenesin 100 mg (expectorant)

dextromethorphan HBr 5 mg (cough suppressant)

phenylephrine HCl 2.5 mg (nasal decongestant)

multi-symptom cold

relieves:

stuffy nose

cough

chest congestion

breaks up mucus

for ages 4 to 12

berry flavor

4 FL OZ (118mL)