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  5. Label Information: Robitussin Childrens Honey Day Night Dm Value Pack

FDA Label for Robitussin Childrens Honey Day Night Dm Value Pack

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH 10 ML) – CHILDREN’S ROBITUSSIN HONEY COUGH & CHEST CONGESTION DM
    2. PURPOSES – CHILDREN’S ROBITUSSIN HONEY COUGH & CHEST CONGESTION DM
    3. USES – CHILDREN’S ROBITUSSIN HONEY COUGH & CHEST CONGESTION DM
    4. DO NOT USE
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. STOP USE AND ASK A DOCTOR IF
    7. IF PREGNANT OR BREAST-FEEDING,
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DIRECTIONS – CHILDREN’S ROBITUSSIN HONEY COUGH & CHEST CONGESTION DM
    10. OTHER INFORMATION – CHILDREN’S ROBITUSSIN HONEY COUGH & CHEST CONGESTION DM
    11. INACTIVE INGREDIENTS – CHILDREN’S ROBITUSSIN HONEY COUGH & CHEST CONGESTION DM
    12. QUESTIONS OR COMMENTS? – CHILDREN’S ROBITUSSIN HONEY COUGH & CHEST CONGESTION DM
    13. ACTIVE INGREDIENTS (IN EACH 10 ML) – CHILDREN’S ROBITUSSIN HONEY NIGHTTIMECOUGH DM
    14. PURPOSES – CHILDREN’S ROBITUSSIN HONEY NIGHTTIME COUGH DM
    15. USES – CHILDREN’S ROBITUSSIN HONEY NIGHTTIME COUGH DM
    16. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    17. WHEN USING THIS PRODUCT
    18. DIRECTIONS – CHILDREN’S ROBITUSSIN HONEY NIGHTTIME COUGH DM
    19. OTHER INFORMATION– CHILDREN’S ROBITUSSIN HONEY NIGHTTIME COUGH DM
    20. INACTIVE INGREDIENTS– CHILDREN’S ROBITUSSIN HONEY NIGHTTIME COUGH DM
    21. QUESTIONS OR COMMENTS? – CHILDREN’S ROBITUSSIN HONEY NIGHTTIME COUGH DM
    22. ADDITIONAL INFORMATION
    23. PRINCIPAL DISPLAY PANEL – CHILDREN’S ROBITUSSIN HONEY DAY NIGHT VALUE PACK
    24. PRINCIPAL DISPLAY PANEL – CHILDREN’S ROBITUSSIN HONEY COUGH & CHEST CONGESTION DM
    25. PRINCIPAL DISPLAY PANEL – CHILDREN’S ROBITUSSIN HONEY NIGHTTIME COUGH DM

Robitussin Childrens Honey Day Night Dm Value Pack Product Label

The following document was submitted to the FDA by the labeler of this product Haleon Us Holdings Llc. 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.

Active Ingredients (In Each 10 Ml) – Children’S Robitussin Honey Cough & Chest Congestion Dm



Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 100 mg


Purposes – Children’S Robitussin Honey Cough & Chest Congestion Dm



Cough Suppressant

Expectorant


Uses – Children’S Robitussin Honey Cough & Chest Congestion Dm



  • ▪temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • ▪helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tube

Do Not Use



if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product

  • ▪to sedate a child or to make a child sleepy
  • ▪if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask A Doctor Before Use If You Have



  • ▪cough that occurs with too much phlegm (mucus)
  • ▪cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • ▪trouble urinating due to an enlarged prostate gland
    • ▪glaucoma
    • ▪a cough that occurs with too much phlegm (mucus)
    • ▪a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema

Stop Use And Ask A Doctor If



cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache.

These could be signs of a serious condition.

cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache.

These could be signs of a serious condition.


If Pregnant Or Breast-Feeding,



ask a health professional before use.

ask a health professional before use.


Keep Out Of Reach Of Children.



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

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


Directions – Children’S Robitussin Honey Cough & Chest Congestion Dm



  • ▪do not take more than 6 doses in any 24-hour period
  • ▪measure only with dosing cup provided
  • ▪keep dosing cup with product
  • ▪mL = milliliter

    • age

    dose

    children under 4 years

    do not use

    children 4 to under 6 years

    5 mL every 4 hours

    children 6 to under 12 years

    10 mL every 4 hours

    adults and children 12 years and over

    20 mL every 4 hours


Other Information – Children’S Robitussin Honey Cough & Chest Congestion Dm



  • ▪each 10 mL contains: sodium 11 mg
  • ▪store at 20-25°C (68-77°F). Do not refrigerate.

Inactive Ingredients – Children’S Robitussin Honey Cough & Chest Congestion Dm



anhydrous citric acid, blueberry juice concentrate, carboxymethylcellulose sodium, glycerin, lactic acid, natural and artificial flavors, natural grade A honey, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium gluconate, sucralose, xanthan gum, zinc gluconate


Questions Or Comments? – Children’S Robitussin Honey Cough & Chest Congestion Dm



call weekdays from 9 AM to 5 PM EST at 1-800-245-1040


Active Ingredients (In Each 10 Ml) – Children’S Robitussin Honey Nighttimecough Dm



Dextromethorphan HBr, USP 15 mg

Doxylamine succinate, USP 6.25 mg


Purposes – Children’S Robitussin Honey Nighttime Cough Dm



Cough suppressant

Antihistamine


Uses – Children’S Robitussin Honey Nighttime Cough Dm



  • ▪temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • ▪temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • ▪runny nose
    • ▪sneezing
    • ▪itchy, watery eyes
    • ▪itching of the nose or throat
    • ▪controls the impulse to cough to help you sleep

Ask A Doctor Or Pharmacist Before Use If You Are



taking sedatives or tranquilizers


When Using This Product



  • ▪do not use more than directed
  • ▪marked drowsiness may occur
  • ▪avoid alcoholic drinks
  • ▪alcohol, sedatives, and tranquilizers may increase drowsiness
  • ▪be careful when driving a motor vehicle or operating machinery
  • ▪excitability may occur, especially in children

Directions – Children’S Robitussin Honey Nighttime Cough Dm



measure only with dosing cup provided

keep dosing cup with product

mL = milliliter

do not take more than 4 doses in any 24-hour period

age

dose

children under 6 years

do not use

children 6 to 12 years

10 mL every 6 hours

adults and children 12 years and older

20 mL every 6 hours


Other Information– Children’S Robitussin Honey Nighttime Cough Dm



  • ▪each 10 mL contains: sodium 10 mg
  • ▪store at 20-25°C (68-77°F)

Inactive Ingredients– Children’S Robitussin Honey Nighttime Cough Dm



anhydrous citric acid, blueberry juice concentrate, carboxymethylcellulose sodium, glycerin, lactic acid, natural and artificial flavors, natural grade A honey, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium gluconate, sucralose, xanthan gum, zinc gluconate


Questions Or Comments? – Children’S Robitussin Honey Nighttime Cough Dm



call weekdays from 9 AM to 5 PM EST at 1-800-245-1040


Additional Information



Packaged with Tamper-Evident bottle cap. Do Not Use if breakable ring is separated or missing.

Do not take both products within 6 hours of each other.

Honey

This dynamic duo combines the great taste of natural honey with the effective cough relief of Robitussin you trust to help your child feel better.

Made with Real Honey

TRUE SOURCE CERTIFIED HONEY

Gluten Free

No Artificial Colors

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org


Principal Display Panel – Children’S Robitussin Honey Day Night Value Pack



Value Pack

Day Night

Children’s

Robitussin

Honey

For Ages 4+

Cough & Chest Congestion DM

DEXTROMETHORPHAN HBr

(Cough Suppressant)

GUAIFENESIN (Expectorant)

Relieves:

  • ✓Chest congestion
  • ✓Mucus
  • ✓Cough

    • Taste the Real Honey

    TRUE SOURCE CERTIFIED HONEY

    4 FL OZ (118 mL)

    Children’s

    Robitussin

    Honey

    For ages 6+

    Nighttime Cough DM

    DEXTROMETHORPHAN HBr

    (Cough Suppressant)

    DOXYLAMINE SUCCINATE (Antihistamine)

    ALCOHOL FREE

    LONG-ACTING

    Relieves:

    Cough up to 8 hours

    Runny nose

    Taste the Real Honey

    TRUE SOURCE CERTIFIED HONEY

    4 FL OZ (118 mL)


Principal Display Panel – Children’S Robitussin Honey Cough & Chest Congestion Dm



Children’s

Robitussin

Honey

For Ages 4+

Cough & Chest Congestion DM

DEXTROMETHORPHAN HBr

(Cough Suppressant)

GUAIFENESIN (Expectorant)

Relieves:

  • ✓Chest congestion
  • ✓Mucus
  • ✓Cough

    • Taste the Real Honey

    TRUE SOURCE CERTIFIED HONEY

    4 FL OZ (118 mL)


Principal Display Panel – Children’S Robitussin Honey Nighttime Cough Dm



Children’s

Robitussin

Honey

For ages 6+

Nighttime Cough DM

DEXTROMETHORPHAN HBr

(Cough Suppressant)

DOXYLAMINE SUCCINATE (Antihistamine)

ALCOHOL FREE

LONG-ACTING

Relieves:

Cough up to 8 hours

Runny nose

Taste the Real Honey

TRUE SOURCE CERTIFIED HONEY

4 FL OZ (118 mL)


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