Equate Children's Multi-symptom Cold & Fever Liquid

Equate Children's Multi-symptom Cold & Fever Liquid
SPL v1
SPL
SPL Set ID 7bf30c75-e867-4a2f-a481-702d7aa96c23
Route
ORAL
Published
Effective Date 2018-01-08
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Guaifenesin (200 mg) Phenylephrine (5 mg)
Inactive Ingredients
Anhydrous Citric Acid Edetate Disodium Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Propylene Glycol Propyl Gallate Water Sodium Benzoate Sodium Citrate, Unspecified Form Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-08-01

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenyephrine HCl 5 mg

Purpose

Pain reliever / fever reducer Cough Suppressant Expectorant Nasal decongestant


Medication Information

Purpose

Pain reliever / fever reducer

Cough Suppressant

Expectorant

Nasal decongestant

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenyephrine HCl 5 mg

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. 

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.
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.
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

1-888-287-1915

Principal Display Panel

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)



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.

Active Ingredients (in Each 10 Ml)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenyephrine HCl 5 mg

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

Structured Label Content

Use(s) (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
Purpose (PURPOSE)

Pain reliever / fever reducer

Cough Suppressant

Expectorant

Nasal decongestant

Warnings (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. 

Directions (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.
Do Not Use (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.
Other Information (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 (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 (QUESTIONS OR COMMENTS)

1-888-287-1915

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

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)



When Using This Product (WHEN USING THIS PRODUCT)

do not use more than directed

Stop Use and Ask Doctor If (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 (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.

Active Ingredients (in Each 10 Ml) (ACTIVE INGREDIENTS (in each 10 mL))

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenyephrine HCl 5 mg

Ask A Doctor Before Use If the Child Has (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 (ASK A DOCTOR OR PHARMACIST BEFORE USE IF)
  • your child is taking the blood thinning drug warfarin

Advanced Ingredient Data


Raw Label Data

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