Up&up Daytime Nighttime Children's Multi Symptom Cold Drug Facts

Up&up Daytime Nighttime Children's Multi Symptom Cold Drug Facts
SPL v2
SPL
SPL Set ID b8a4da0b-e4d3-48e6-b699-cb56c7b67ed7
Route
ORAL
Published
Effective Date 2024-08-05
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 Disodium Fd&c Blue No. 1 Fd&c Red No. 40 Potassium Citrate Propyl Gallate Propylene Glycol Water Sodium Benzoate Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: pink Color: blue
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-19

Description

Day Time Multi-Symptom Cold DO NOT TAKE BOTH PRODUCTS WITHIN 4 HOURS OF EACH OTHER Drug Facts


Medication Information

Description

Day Time Multi-Symptom Cold DO NOT TAKE BOTH PRODUCTS WITHIN 4 HOURS OF EACH OTHER Drug Facts

Uses
  • 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
Section 42229-5

Day Time Multi-Symptom Cold

DO NOT TAKE BOTH PRODUCTS WITHIN 4 HOURS OF EACH OTHER

Drug Facts

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if

  • nervousness, dizziness or sleeplessness occur
  • symptoms do not get better within 7 days or occur with fever
  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.
Section 50567-7

When using this productdo not use more than directed

Section 50569-3

Ask a doctor before use if the child has

  • 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
Section 50570-1

Do not usein 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.

Section 55105-1
Active ingredients (in each 5 mL) Purposes

Dextromethorphan HBr 5 mg

Cough suppressant

Guaifenesin 100 mg

Expectorant

Phenylephrine HCl 2.5 mg

Nasal decongestant

Directions
  • do not give 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
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
  • 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 drug 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.
Questions?

1-866-467-2748.

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

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.

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 for adults as well as for children even if you do not notice any signs or symptoms.

Other Information
  • each 5 mL contains:sodium 2 mg
  • store at room temperature
  • do not refrigerate
  • dosing cup provided
Inactive Ingredients

anhydrous citric acid, edetate disodium, FD&C Blue No.1, FD&C Red #40, flavors, potassium citrate, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Questions Or Comments?

1-866-467-2748

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 drowsiness
Stop Use and Ask A 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 fever, rash, or headache that lasts. These could be signs of a serious condition.
Principal Display Panel Kit Carton

VALUE

PACK

Compare to active ingredients in Children’s Mucinex® Multi-Symptom Cold* and Children’s Mucinex® Nighttime Multi-Symptom Cold**

NDC 82442-476-08

Daytime Nighttime Children’s Multi-Symptom Cold



Dextromethorphan HBr 5 mg (Cough Suppressant)

Guaifenesin 100 mg (Expectorant)

Phenylephrine HCl 2.5 mg (Nasal Decongestant)

  • Breaks up Mucus
  • Provides relief from stuffy nose, cough and chest congestion

Age 4 to 11 Years

Dosage Cup Included

Berry Flavor

NATURALLY AND ARTIFICIALLY FLAVORED

4 FL OZ (118 mL)

NIGHTTIME

Multi-Symptom

Cold

Acetaminophen 325 mg(Pain Reliever/Fever Reducer)

Diphenhydramine HCl 12.5 mg (Antihistamine/Cough Suppressant)

Phenylephrine HCl 5 mg (Nasal Decongestant)

  • Provides relief from sneezing, stuffy or runny nose, cough, fever and sore throat

Very Berry Flavor

NATURALLY AND ARTIFICIALLY FLAVORED

Ages 6 to 11 years

Dosage Cup Included

4 FL OZ (118 mL)

8 FL OZ (236 mL) TOTAL

* This product is not manufactured or distributed by RB Health (US), distributor of Children’s Mucinex® Multi-Symptom Cold.

**This product is not manufactured or distributed by RB Health (US), distributor of Children’s Mucinex® Nighttime Multi-Symptom Cold.

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

Important: Keep this carton for future reference for full labeling.

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

Structured Label Content

Uses
  • 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
Section 42229-5 (42229-5)

Day Time Multi-Symptom Cold

DO NOT TAKE BOTH PRODUCTS WITHIN 4 HOURS OF EACH OTHER

Drug Facts

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • nervousness, dizziness or sleeplessness occur
  • symptoms do not get better within 7 days or occur with fever
  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.
Section 50567-7 (50567-7)

When using this productdo not use more than directed

Section 50569-3 (50569-3)

Ask a doctor before use if the child has

  • 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
Section 50570-1 (50570-1)

Do not usein 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.

Section 55105-1 (55105-1)
Active ingredients (in each 5 mL) Purposes

Dextromethorphan HBr 5 mg

Cough suppressant

Guaifenesin 100 mg

Expectorant

Phenylephrine HCl 2.5 mg

Nasal decongestant

Directions
  • do not give 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
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)
  • 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 drug 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.
Questions?

1-866-467-2748.

Liver Warning (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

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.

Overdose Warning (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 for adults as well as for children even if you do not notice any signs or symptoms.

Other Information (Other information)
  • each 5 mL contains:sodium 2 mg
  • store at room temperature
  • do not refrigerate
  • dosing cup provided
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, edetate disodium, FD&C Blue No.1, FD&C Red #40, flavors, potassium citrate, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Questions Or Comments? (Questions or comments?)

1-866-467-2748

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 drowsiness
Stop Use and Ask A Doctor If (Stop use and ask a 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 fever, rash, or headache that lasts. These could be signs of a serious condition.
Principal Display Panel Kit Carton (PRINCIPAL DISPLAY PANEL - Kit Carton)

VALUE

PACK

Compare to active ingredients in Children’s Mucinex® Multi-Symptom Cold* and Children’s Mucinex® Nighttime Multi-Symptom Cold**

NDC 82442-476-08

Daytime Nighttime Children’s Multi-Symptom Cold



Dextromethorphan HBr 5 mg (Cough Suppressant)

Guaifenesin 100 mg (Expectorant)

Phenylephrine HCl 2.5 mg (Nasal Decongestant)

  • Breaks up Mucus
  • Provides relief from stuffy nose, cough and chest congestion

Age 4 to 11 Years

Dosage Cup Included

Berry Flavor

NATURALLY AND ARTIFICIALLY FLAVORED

4 FL OZ (118 mL)

NIGHTTIME

Multi-Symptom

Cold

Acetaminophen 325 mg(Pain Reliever/Fever Reducer)

Diphenhydramine HCl 12.5 mg (Antihistamine/Cough Suppressant)

Phenylephrine HCl 5 mg (Nasal Decongestant)

  • Provides relief from sneezing, stuffy or runny nose, cough, fever and sore throat

Very Berry Flavor

NATURALLY AND ARTIFICIALLY FLAVORED

Ages 6 to 11 years

Dosage Cup Included

4 FL OZ (118 mL)

8 FL OZ (236 mL) TOTAL

* This product is not manufactured or distributed by RB Health (US), distributor of Children’s Mucinex® Multi-Symptom Cold.

**This product is not manufactured or distributed by RB Health (US), distributor of Children’s Mucinex® Nighttime Multi-Symptom Cold.

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

Important: Keep this carton for future reference for full labeling.

Ask A Doctor Before Use If Your Child Has (Ask a doctor before use if your child has)
  • liver disease
  • heart disease
  • diabetes
  • high blood pressure
  • 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 Your Child Is (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

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