FDA Label for Up And Up Daytime Nighttime Childrens Multi Symptom Cold

View Indications, Usage & Precautions

Up And Up Daytime Nighttime Childrens Multi Symptom Cold Product Label

The following document was submitted to the FDA by the labeler of this product Target Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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Day Time Multi-Symptom Cold

DO NOT TAKE BOTH PRODUCTS WITHIN 4 HOURS OF EACH OTHER

Drug Facts

Nighttime Children’s Multi-Symptom Cold

DO NOT TAKE BOTH PRODUCTS WITHIN 4 HOURS OF EACH OTHER

Drug Facts

Dist. by: Target Corporation

Minneapolis, MN 55403

Made In the U.S.A.

With domestic and imported ingredients.

TM & © 2024 Target Brands, Inc.


Otc - Purpose



Active ingredients (in each 5 mL)Purposes

Dextromethorphan HBr 5 mg

Cough suppressant

Guaifenesin 100 mg

Expectorant

Phenylephrine HCl 2.5 mg

Nasal decongestant

Active ingredients (in each 10 mL)Purposes

Acetaminophen 325 mg

Pain reliever/fever reducer

Diphenhydramine HCl 12.5 mg

Antihistamine/cough suppressant

Phenylephrine HCl 5 mg

Nasal decongestant


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
      • temporarily relieves these common cold and flu symptoms:
        • minor aches and pains
        • headache
        • sore throat
        • nasal congestion
        • runny nose
        • sneezing
        • cough
        • controls cough to help your child get to sleep
        • temporarily reduces fever

Otc - Do Not Use



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.


Otc - Ask Doctor



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

Otc - When Using



When using this productdo not use more than directed


Otc - Stop Use



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.

Otc - Keep Out Of Reach Of Children



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.

Keep out of reach of children.


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
  • AgeDose

    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

    • this product does not contain directions or complete warnings for adult use
    • do not give more than directed (see Overdose warning)
    • 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 every 4 hours; do not give more than 5 doses in any 24-hour period
    • children under 6 years of age: do not use

Other Information



  • each 5 mL contains:sodium 2 mg
  • store at room temperature
  • do not refrigerate
  • dosing cup provided
    • each 10 mL contains:sodium 4 mg
    • store at room temperature
    • do not refrigerate

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

anhydrous citric acid, edetate disodium, FD&C Blue #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


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.


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.

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

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.

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.


Questions?



1-866-467-2748.


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.


* Please review the disclaimer below.