Equate Children's Multi-symptom Cold Nighttime

Equate Children's Multi-symptom Cold Nighttime
SPL v4
SPL
SPL Set ID bfdaec98-24fe-47e1-ad32-dc2ddc4ce8ee
Route
ORAL
Published
Effective Date 2024-12-20
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Diphenhydramine (12.5 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 Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

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

Description

Acetaminophen 325 mg Diphenhydramine HCl 12.5 mg Phenyephrine HCl 5 mg

Purpose

Pain reliever / fever reducer Antihistamine/Cough Suppressant Nasal decongestant


Medication Information

Purpose

Pain reliever / fever reducer

Antihistamine/Cough Suppressant

Nasal decongestant

Description

Acetaminophen 325 mg Diphenhydramine HCl 12.5 mg Phenyephrine HCl 5 mg

Use(s)

temporarily relieves these common cold and flu symptoms:

  • cough 
  • sore throat
  • nasal congestion
  • runny nose
  • minor aches and pains
  • headache
  • sinus congestion and pressure
  • sneezing
  • temporarily reduces fever
  • controls cough to help your child get to sleep
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
  • mL = milliliter
  • Children 6 to under 12 years of age: 10 mL in dosing cup provided.
  • 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.
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on the skin.
  • 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 49035-623-03

equate

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

Children's 

  MULTI-SYMPTOMS COLD 

NIGHTTIME

Acetaminophen 325 mg

Pain reliever/Fever Reducer

Diphenhydramine HCl 12.5 mg

Antihistamine/Cough Suppressant 

Phenylephrine HCl 5 mg

Nasal Decongestant



AGES 6 to 12 YEARS





  • Relieves headache and fever
  • Soothes cough
  • Relieves nasal congestion 
  • Relieves runny nose and sneezing


 Mixed Berry Flavored





 4 FL OZ (118 mL)







When Using This Product
  • do not use more than directed (see Overdose warning)
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • sedatives and tranquilizers may increase dowsiness
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

Diphenhydramine HCl 12.5 mg

Phenyephrine HCl 5 mg

Ask A Doctor Before Use If the Child Has
  • liver disease
  • thyroid disease
  • diabetes
  • heart disease
  • high blood pressure
  • 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 Your Child 
  • is taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

Structured Label Content

Use(s) (USE(S))

temporarily relieves these common cold and flu symptoms:

  • cough 
  • sore throat
  • nasal congestion
  • runny nose
  • minor aches and pains
  • headache
  • sinus congestion and pressure
  • sneezing
  • temporarily reduces fever
  • controls cough to help your child get to sleep
Purpose (PURPOSE)

Pain reliever / fever reducer

Antihistamine/Cough Suppressant

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
  • mL = milliliter
  • Children 6 to under 12 years of age: 10 mL in dosing cup provided.
  • 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.
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on the skin.
  • 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 49035-623-03

equate

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

Children's 

  MULTI-SYMPTOMS COLD 

NIGHTTIME

Acetaminophen 325 mg

Pain reliever/Fever Reducer

Diphenhydramine HCl 12.5 mg

Antihistamine/Cough Suppressant 

Phenylephrine HCl 5 mg

Nasal Decongestant



AGES 6 to 12 YEARS





  • Relieves headache and fever
  • Soothes cough
  • Relieves nasal congestion 
  • Relieves runny nose and sneezing


 Mixed Berry Flavored





 4 FL OZ (118 mL)







When Using This Product (WHEN USING THIS PRODUCT)
  • do not use more than directed (see Overdose warning)
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • sedatives and tranquilizers may increase dowsiness
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

Diphenhydramine HCl 12.5 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
  • 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 Your Child  (ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOUR CHILD )
  • is taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)