Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID e3da3003-88e3-4431-8b65-e61e17728901
Route
ORAL
Published
Effective Date 2024-06-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (5 mg) Guaifenesin (100 mg) Phenylephrine (2.5 mg) Acetaminophen (325 mg) Diphenhydramine (12.5 mg)
Inactive Ingredients
Anhydrous Citric Acid Edetate Calcium Disodium Fd&c Red No. 40 Glycerin Propyl Gallate Propylene Glycol Water Sodium Benzoate Sodium Citrate Sorbitol Sucralose Xanthan Gum Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-02-28

Description

Acetaminophen 325 mg Diphenhydramine HCI 12.5 mg Phenylephrine HCl 5 mg

Purpose

Cough suppressant Expectorant Nasal decongestant


Medication Information

Purpose

Cough suppressant Expectorant Nasal decongestant

Description

Acetaminophen 325 mg Diphenhydramine HCI 12.5 mg Phenylephrine HCl 5 mg

Uses

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

Daytime

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make cough more productive
  • temporarialy 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
Warnings

NIGHTTIME

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.

Directions

Nighttime

  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed (see Overdose warning)
  • 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 any other dosing device.
  • mL = milliliter
  • dose as follows or as directed by a doctor
  • children 6 to under 12 years of age: 10 mL every 4 hours
  • children under 6 years of age: do not use

Daytime

  • do not take more than 6 doses in any 24-hours period
  • use only the enclosed dosing cup designed for use with this product. Do not use any other dosing device
  • keep dosing cup with product
  • dose as follows, or as directed by a doctor
  • mL = milliliter
Age Dose 
 children 6 years to under 12 years  10 mL every 4 hours
 children 4 years to under 6 years  5 mL every 4 hours
 children under 4 years  do not use


Do Not Use

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 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 drug containing diphenhydramine, even one used on skin.
  • If your child is allergic to acetaminophen or any of the inactive ingredients in this product
  • to make a child sleepy

Daytime

  • in a child who is taking a prescription monoamine oxidase inhibitor (MAOI)(certain drugs for depression,psychiatic 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. 
Product Label
TARGET Children's Daytime Nighttime Multi-Symptom Cold Relief
Other Information

Nighttime

  • each 10 mL contains: sodium 6 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate.

Daytime

  • each 5 mL contains: sodium 5 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate.
Purpose for Daytime

Cough suppressant

Expectorant

Nasal decongestant

Inactive Ingredients

Nighttime

citric acid, disodium EDTA, FD&C Blue #1, FD&C red #40, Flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Daytime

citric acid, disodium EDTA, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose xanthan gum

Purpose for Nighttime

Pain reliever / fever reducer

Antihistamine / Cough suppressant

Nasal Decongestant

Questions Or Comments?

Call 1-800-910-6874

Principal Display Panel

NIGHTTIME

Compare to active ingredients in Children's Mucinex® Night Time Multi-Symptom Cold*

Children's night time

multi-symptom

Cold Relief

acetaminophen 325 mg (pain reliever / fever reducer)

diphenhydramine HCI 12.5 mg (Antihistamine-Cough Suppressant)

phenylephrine HCI 5 mg (Nasal Decongestant)

relieves

stuffy nose

cough

runny nose and sneezing

fever and sore throat

alcohol free

BERRY FLAVOR

DOSING CUP INCLUDED

AGES 6 - 11 YEARS

FL OZ (mL)

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

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

DAYTIME

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

Children's

daytime

multi-symptom cold relief

dextromethorphan HBr 5 mg (Cough Suppressant)

guaifenesin 100 mg (expectorant)

phenylephrine HCl 2.5 mg (Nasal Decongestant)

relieves stuffy nose

controls cough

chest congestion

breaks up mucus

alcohol free

BERRY FLAVOR

DOSING CUP INCLUDED

AGES  4 to 11 YEARS

FL OZ (mL)

Distributed by Target Corporation

Minneapolis, MN 55403

When Using These Products

Nighttime

  • do not use more than directed
  • marked drowsiness may occur
  • excitablity may occur, especially in children
  • sedatives and tranquilizer may increase drowsiness

Daytime

  • do not use more than directed
Stop Use and Ask A Doctor If

Nighttime

  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, or cough gets worse or last more than 5 days
  • redness or swelling is present
  • new symptoms occurs
  • 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 conditions.

Daytime

  • nervousness, dizziness or sleeplessness occur
  • symptoms do not better within 7 days or occur with fever
  • cough lasts more than 7 days, comes back or occur with a fever, rash, or headache that lasts. These could be signs of a serious condition.
Keep Out of Reach of Children.

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 (1-800-222-1222). Quick medical attention is critical even if you do not notice any sign or symptoms.

Daytime

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

Ask A Doctor Before Use If You Have

Nighttime

  • liver disease
  • heart disease 
  • thyroid disease
  • diabetes
  • glaucoma
  • 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)

Daytime

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with asthma
Active Ingredients for Daytime (in Each 5 Ml)

Dextromethorphan HBr 5 mg

Guaifenesin 100 mg

Phenylephrine HCl 2.5 mg

Active Ingredients for Nighttime (in Each 10 Ml)

Acetaminophen 325 mg

Diphenhydramine HCI 12.5 mg

Phenylephrine HCl 5 mg

Ask A Doctor Or Pharmacist Before Use If You Are

Nighttime

  • taking the blood thinning drug warfain
  • taking sedative or tranquilizers

Structured Label Content

Uses

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

Daytime

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make cough more productive
  • temporarialy 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
Warnings

NIGHTTIME

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.

Directions

Nighttime

  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed (see Overdose warning)
  • 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 any other dosing device.
  • mL = milliliter
  • dose as follows or as directed by a doctor
  • children 6 to under 12 years of age: 10 mL every 4 hours
  • children under 6 years of age: do not use

Daytime

  • do not take more than 6 doses in any 24-hours period
  • use only the enclosed dosing cup designed for use with this product. Do not use any other dosing device
  • keep dosing cup with product
  • dose as follows, or as directed by a doctor
  • mL = milliliter
Age Dose 
 children 6 years to under 12 years  10 mL every 4 hours
 children 4 years to under 6 years  5 mL every 4 hours
 children under 4 years  do not use


Do Not Use (Do not use)

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 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 drug containing diphenhydramine, even one used on skin.
  • If your child is allergic to acetaminophen or any of the inactive ingredients in this product
  • to make a child sleepy

Daytime

  • in a child who is taking a prescription monoamine oxidase inhibitor (MAOI)(certain drugs for depression,psychiatic 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. 
Product Label
TARGET Children's Daytime Nighttime Multi-Symptom Cold Relief
Other Information (Other information)

Nighttime

  • each 10 mL contains: sodium 6 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate.

Daytime

  • each 5 mL contains: sodium 5 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate.
Purpose for Daytime

Cough suppressant

Expectorant

Nasal decongestant

Inactive Ingredients (Inactive ingredients)

Nighttime

citric acid, disodium EDTA, FD&C Blue #1, FD&C red #40, Flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Daytime

citric acid, disodium EDTA, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose xanthan gum

Purpose for Nighttime

Pain reliever / fever reducer

Antihistamine / Cough suppressant

Nasal Decongestant

Questions Or Comments? (Questions or comments?)

Call 1-800-910-6874

Principal Display Panel

NIGHTTIME

Compare to active ingredients in Children's Mucinex® Night Time Multi-Symptom Cold*

Children's night time

multi-symptom

Cold Relief

acetaminophen 325 mg (pain reliever / fever reducer)

diphenhydramine HCI 12.5 mg (Antihistamine-Cough Suppressant)

phenylephrine HCI 5 mg (Nasal Decongestant)

relieves

stuffy nose

cough

runny nose and sneezing

fever and sore throat

alcohol free

BERRY FLAVOR

DOSING CUP INCLUDED

AGES 6 - 11 YEARS

FL OZ (mL)

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

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

DAYTIME

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

Children's

daytime

multi-symptom cold relief

dextromethorphan HBr 5 mg (Cough Suppressant)

guaifenesin 100 mg (expectorant)

phenylephrine HCl 2.5 mg (Nasal Decongestant)

relieves stuffy nose

controls cough

chest congestion

breaks up mucus

alcohol free

BERRY FLAVOR

DOSING CUP INCLUDED

AGES  4 to 11 YEARS

FL OZ (mL)

Distributed by Target Corporation

Minneapolis, MN 55403

When Using These Products (When using these products)

Nighttime

  • do not use more than directed
  • marked drowsiness may occur
  • excitablity may occur, especially in children
  • sedatives and tranquilizer may increase drowsiness

Daytime

  • do not use more than directed
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

Nighttime

  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, or cough gets worse or last more than 5 days
  • redness or swelling is present
  • new symptoms occurs
  • 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 conditions.

Daytime

  • nervousness, dizziness or sleeplessness occur
  • symptoms do not better within 7 days or occur with fever
  • cough lasts more than 7 days, comes back or occur with a fever, 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.)

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 (1-800-222-1222). Quick medical attention is critical even if you do not notice any sign or symptoms.

Daytime

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

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

Nighttime

  • liver disease
  • heart disease 
  • thyroid disease
  • diabetes
  • glaucoma
  • 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)

Daytime

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with asthma
Active Ingredients for Daytime (in Each 5 Ml) (Active ingredients for Daytime (in each 5 mL))

Dextromethorphan HBr 5 mg

Guaifenesin 100 mg

Phenylephrine HCl 2.5 mg

Active Ingredients for Nighttime (in Each 10 Ml) (Active ingredients for Nighttime (in each 10 mL))

Acetaminophen 325 mg

Diphenhydramine HCI 12.5 mg

Phenylephrine HCl 5 mg

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

Nighttime

  • taking the blood thinning drug warfain
  • taking sedative or tranquilizers

Advanced Ingredient Data


Raw Label Data

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