Daytime Nighttime Childrens Multi-symptom Cold Kit
FDA Label NDC 49035-938

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Wal-mart Stores, Inc. for the product Daytime Nighttime Childrens Multi-symptom Cold (NDC 49035-938). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient(s) for daytime (in each 5 ml), active ingredient(s) for nighttime (in each 10 ml), purpose for daytime, purpose for nighttime, use(s), warnings, do not use, ask a doctor before use if child has, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient(S) For Daytime (In Each 5 Ml)

Dextromethorphan HBr 5mg

Guaifenesin 100 mg

Phenylephrine HCl 2.5 mg

Active Ingredient(S) For Nighttime (In Each 10 Ml)

Acetaminophen 325 mg
Diphenhydramine HCl 12.5 mg
Phenylephrine HCl 5 mg

Purpose For Daytime

Cough Suppressant

Expectorant

Nasal decongestant

Purpose For Nighttime

Pain reliever/fever reducer
Antihistamine/Cough Suppressant
Nasal decongestant

Use(S)


DAYTIME

  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
  • temporarily relieves:
  • cough due to minor throat and bronchial irritation as may occur with a 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

    • NIGHTTIME


    • 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

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.

Do Not Use

DAYTIME
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.

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.
  • 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 MAOI drug. If you do not know if your child prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask A Doctor Before Use If Child Has


DAYTIME

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • persistent or chronic cough such as occurs with asthma
  • cough that occurs with too much phlegm (mucus)

    • NIGHTTIME


    • 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

NIGHTTIME


  • is taking the blood thinning drug warfarin 
  • taking sedatives or tranquilizers 

When Using This Product

DAYTIME 

do not use more than directed

NIGHTTIME

  • 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 Doctor If


DAYTIME

  • your child gets nervous, dizzy or sleepless
  • 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 illness.

    NIGHTTIME


    • 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.

Keep Out Of Reach Of Children

DAYTIME

In case of overdose, get medical help or contact a Poison Control Center right away.

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. Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions


DAYTIME

  • do not take 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
    • mL = milliliter

      • NIGHTTIME


      • 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.

Other Information


DAYTIME

  • each 5 mL contains: potassium 5 mg, sodium 5 mg
  • store between 15-30°C (59-86°F)
  • do not refrigerate
  • dosing cup provided


    • NIGHTTIME


    • each 10 mL contains: sodium 10 mg
    • store between 15-30°C (59-86°F)
    • do not refrigerate
    • dosing cup provided

Inactive Ingredients

DAYTIME

citric acid anhydrous, D&C red # 33, dextrose, edetate disodium, FD&C blue # 1, FD&C Red #40, flavor, glycerin, methylparaben, potassium sorbate, propyl gallate, propylene glycol, propylparaben, purified water, saccharin sodium, sodium hydroxide, sorbitol solution, sucralose, xanthan gum.

NIGHTTIME
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?

call 1-888-287-1915

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DAY & NIGHT VALUE PACK

NDC 49035-938-04

equateTM

Compare to Children's Mucinex®Multi-Symptom Cold Active Ingredients*

Daytime

Ages 4-12 years

Children's Multi-Symptom Cold
Dextromethorphan HBr 5mg   - Cough Suppressant 

Guaifenesin100mg - Expectorant

Phenylephrine HCl 2.5 mg - Nasal Decongestant

  •  Relieves Stuffy Nose
    • Soothes Cough
    • Relieves Chest Congestion
    • Thins & loosens Mucus

      • Very Berry Flavored 

      Dosage cup included

      NIGHTTIME

      Ages 6-12 yearsChildren's Multi-Symptom ColdAcetaminophen 325mg - Pain reliever/fever reducerDiphenhydramine HCl 12.5mg - Antihistamine/cough suppressant
      Phenylephrine HCl 5 mg - Nasal Decongestant

      • Temporarily reduces fever
      • Soothes cough & sore throat
      • Relieves nasal congestion & sneezing

        • Mixed berry flavored Dosage Cup Included
        TWO 4 FL OZ (118 mL) BOTTLES / 8 FL OZ (236 mL) TOTAL

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* Please review the disclaimer below.