1. Home
  2. Labeler Index
  3. Winco Foods, Llc
  4. 67091-221
  5. Label Information: Childrens Multi-symptom Cold And Fever Relief

FDA Label for Childrens Multi-symptom Cold And Fever Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH 10 ML)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF THE CHILD HAS
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. KEEP OUT OF REACH OF CHILDREN.
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS?
    15. PDP

Childrens Multi-symptom Cold And Fever Relief Product Label

The following document was submitted to the FDA by the labeler of this product Winco Foods, Llc. 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 10 Ml)



Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg


Purpose



Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant


Uses



  • temporarily relieves these common cold and flu symptoms:
  • nasal congestion
  • stuffy nose
  • cough due to minor throat and bronchial irritation
  • the intensity of coughing
  • the impulse to cough to help your child get to sleep
  • minor aches and pains
  • sore throat
  • headache
  • temporarily reduces fever
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive

Warnings



  • Liver warning: This product contains acetaminophen. severe liver damage may occur if your child takes
  • more than 5 doses in 24 hours, which is maximum daily amount
  • with other drugs containing acetaminophen
  • Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, vomiting, consult a doctor promptly.

Do Not Use



  • with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • 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 prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask A Doctor Before Use If The Child Has



  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • a breathing problem such as chronic bronchitis
  • persistent or chronic cough such as occurs with smoking, asthma
  • cough that occurs with too much phlegm (mucus)

Ask A Doctor Or Pharmacist Before Use If



you are taking the blood thinning drug warfarin


When Using This Product



  • do not use more than directed

Stop Use And Ask A Doctor If



  • nervousness, dizziness or sleeplessness occur
  • pain, nasal congestion or cough gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back, or occurs with rash or headache. These could be signs of a serious condition.

Keep Out Of Reach Of Children.



Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a poison control center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.


Directions



  • this product does not contain directions or complete warnings for adult use
  • do not take more than directed (see overdose warning)
  • shake well before use
  • do not take more than 5 doses in any 24 hour period
  • if needed, repeat dose every 4 hours while symptoms last
  • do not give more than 5 days unless directed by a doctor
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
  • Children 6 to under 12 years of age: 10 mL in dosing cup provided 
  • Children under 6 years of age: do not use

Other Information



  • each 10 mL contains: sodium 10 mg
  • store between 15-30oC(59-86oF)
  • do not refrigerate
  • dosing cup provided

Inactive Ingredients



citric acid anhydrous, edetate disodium, FD&C blue 1, FD&C red 40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum


Questions?



1-800-824-1706 Monday-Friday 9am-4pm MST

You may also report side effects to this phone number.


Pdp



*Compare to the active ingredients in  Childrens MUCINEX® Multi-symptom Cold and Fever

Childrens Multi-Symptom Cold and Fever Relief

ACETAMINOPHEN 325 mg per 10 mL /PAIN RELIEVER-FEVER REDUCER

DEXTROMETHORPHAN HBr /COUGH SUPPRESSANT

GUAIFENESIN /EXPECTORANT

PHENYLEPHRINE HCl /NASAL DECONGESTANT

Relieves: Cough, Nasal & Chest Congestion

Thins & Loosens Mucus

Reduces fever

For Ages 6-12 Years

Berry Burst Flavor

4 FL OZ (118 mL)

BOX - WC622

BOX - WC622


* Please review the disclaimer below.