FDA Label for Target Childrens Multi Symptom Cold Valur Pack

Children’S Multi-Symptom Cold Active Ingredients  (In Each 5 Ml)

Dextromethorphan HBr 5 mg

Guaifenesin 100 mg

Phenylephrine HCl 2.5 mg

Children’S Night Timemulti-Symptom Cold Active Ingredients (In Each 10 Ml)

Acetaminophen 325 mg

Diphenhydramine HCL12.5 mg

Phenylephrine HCL5 mg

Purposes Forchildren’S Multi-Symptom Cold

Cough suppressant

Expectorant

Nasal decongestant

Purposes Forchildren’S Night Timemulti-Symptom Cold

Pain reliever/fever reducer 

Antihistamine/Cough suppressant

Nasal decongestant

Uses

Daytime

• 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

  Nighttime

  • temporarily relieves these common cold and flu symptoms:
    • minor aches and pains
    • headache
    • sore throat
    • sneezing
    • runny nose
    • nasal congestion
    • cough
    • controls cough to help your child get to sleep
    • temporarily reduces fever 
    
    

Warnings

Nighttime only

Liver warning:This product contains acetaminophen .Severe liver damage may occur if your child takes:

• more than 5 doses in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

• skin reddening
• blisters
• rash

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do Not Use

DAYTIME

• 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.

NIGHTTIME

• with any other drug containing acetaminophen (prescription or nonprescription).  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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
• with any other product containing diphenhydramine even one used on the skin
• to make a child sleepy

Ask A Doctor Before Use Your Child Has

DAYTIME

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

NIGHTTIME

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

Ask A Doctor Or Pharmacist Before Use If The Child Is

NIGHTTIME

• taking sedatives or tranquilizers.
• taking the blood thinning drug warfarin

When Using This Product

Daytime

do not use more than directed.

Nighttime

• do not use more than directed (see overdose warning)
• excitability may occur, especially in children
• marked drowsiness may occur
• sedatives and tranquilizers may increase drowsiness

Stop Use And Ask A Doctor If

DAYTIME

• nervousness, dizziness, or sleeplessness occur
• symptoms do not get better with 7 days or occur with fever
• cough lasts more than 7 days, comes back, or occurs with a fever, rash, or headache that lasts.

These could be signs of a serious condition.

NIGHTTIME

• nervousness, dizziness, or sleeplessness occur
• pain, nasal congestion, or cough gets worse or lasts more than 5 days
• redness or swelling is present
• new symptoms occur
• fever gets worse or lasts more than 3 days
• cough comes back or occurs with rash or headache that lasts.

These could be signs of a serious condition.

Keep Out Of Reach Of Children.

Daytime

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Nighttime

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 at1-800-222-1222. Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

Daytime

• 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 of age	10 mL every 4 hours
children 4 years to under 6 years of age	5 mL every 4 hours
children under 4 years of age	do not use


Nighttime

• this product does not contain directions or complete warnings for adult use
• do not give more than directed (see overdose warning)
• 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 every 4 hours while symptoms last. do not give more than 5 doses in any 24-hour period
• children under 6 years of age: do not use

Other Information

Daytime

• each 5 mL contains:sodium 2 mg
• store at room temperature.
• Do not refrigerate.
• Dosing cup provided

Nighttime

• each 10 mL contains:sodium 4 mg
• store at room temperature.
• Do not refrigerate.

Inactive Ingredients

Inactive ingredients for Day Time 

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

Inactive ingredients for Night Time 

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

Questions Or Comments?

1-866-467-2748

Principal Display Panel

Compare to the active ingredients in Children's Mucinex® Multi-Symptom Cold

Children's

Multi-Symptom Cold

Dextromethorphan HBr - Cough Suppressant

Guaifenesin - Expectorant

Phenylephrine HCI - Nasal Decongestant

• Relieves stuffy nose from
• Controls Cough
• Relieves Chest Congestion
• Breaks up mucus

Dosing Cup Included

For Ages 4 & Over

Berry flavor

Children's

Night Time

Multi-Symptom Cold

Acetaminophen- Pain reliever / Fever Reducer

Diphenhydramine HCI - Antihistamine / Cough Suppressant

Phenylephrine HCI - Nasal Decongestant

• Relieves Stuffy Nose
• Controls Cough,
• Relives Fever& Sore Throat,
• Relieves Runny Nose & Sneezing

Dosing Cup Included

For Ages 6 & Over

Very Berry flavor

2 – 4 FL OZ (118mL) BOTTLES / TOTAL 8 FL OZ (236 mL)

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

IMPORTANT:Keep this carton for future reference for full labeling

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

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