FDA Label for Caring Mill Childrens Mucus Relief

View Indications, Usage & Precautions

Caring Mill Childrens Mucus Relief Product Label

The following document was submitted to the FDA by the labeler of this product Fsa Store Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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

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 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?



1-800-719-9260


Package/Label Principal Display Panel



Compare to the active ingredients of Children’s Mucinex® Multi-Symptom Cold

Ages 4 to 12 Years

Children’s Mucus Relief

Cough Suppressant (Dextromethorphan HBr)

Expectorant (Guaifenesin)

Nasal Decongestant (Phenylephrine HCI)

Multi-Symptom Cold

Berry Flavor Liquid

Relieves:

- Stuffy Nose

- Cough

- Chest Congestion

- Breaks Up Mucus

4 FL OZ (118 mL)


* Please review the disclaimer below.