FDA Label for Childrens Multi-symptom Cold And Fever Liquid

Active Ingredients (In Each 10 Ml)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenyephrine HCl 5 mg

Purpose

Pain reliever / fever reducer

Cough Suppressant

Expectorant

Nasal decongestant

Use(S)

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 hous, 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

• 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.

Ask A Doctor Before Use If The Child Has

• liver disease
• thyroid disease
• diabetes
• heart disease
• high blood pressure
• 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

• your child is taking the blood thinning drug warfarin

When Using This Product

do not use more than directed

Stop Use And Ask 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 that lasts. 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 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 give more than directed (see Overdose warning)
• shake well before use
• do not give 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.
• mL = milliliter
• Children under 6 years of age: do not use.

Other Information

• each 10 mL contains: sodium 10 mg
• store between 15-30°C (59-86°F)
• 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 Or Comments

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NDC 49035-772-03

equate

Compare to Children's Mucinex®Multi-Symptom Cold & Fever active ingredients*

Children's Multi-Symptom Cold & Fever Liquid

Acetaminophen 325 mg
Pain reliever/Fever Reducer

Dextromethorphan HBr 10 mg

Cough Suppressant
Guaifenesin 200 mg

Expectorant
Phenylephrine HCl 5 mg

Nasal Decongestant

AGES 6 to 12 YEARS

• Relieves nasal and chest congestion
• Soothes Cough 
• Reduces fever
• Thins and loosens Mucus
• Alcohol Free
• Berry Burst Flavored 

4 FL OZ (118 mL)


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