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  5. Label Information: Robitussin Day And Night Cough Relief Value Pack

FDA Label for Robitussin Day And Night Cough Relief Value Pack

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH 20 ML)– CHILDREN’S ROBITUSSIN COUGH & CHEST CONGESTION DM
    2. PURPOSES– CHILDREN’S ROBITUSSIN COUGH & CHEST CONGESTION DM
    3. USES– CHILDREN’S ROBITUSSIN 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 COUGH & CHEST CONGESTION DM
    10. OTHER INFORMATION– CHILDREN’S ROBITUSSIN COUGH & CHEST CONGESTION DM
    11. INACTIVE INGREDIENTS– CHILDREN’S ROBITUSSIN COUGH & CHEST CONGESTION DM
    12. QUESTIONS OR COMMENTS?– CHILDREN’S ROBITUSSIN COUGH & CHEST CONGESTION DM
    13. ACTIVE INGREDIENTS (IN EACH 10 ML)– CHILDREN’S ROBITUSSIN NIGHTTIME COUGH LONG-ACTING DM
    14. PURPOSES –CHILDREN’S ROBITUSSIN NIGHTTIME COUGH LONG-ACTING DM
    15. USES –CHILDREN’S ROBITUSSIN NIGHTTIME COUGH LONG-ACTING DM
    16. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    17. WHEN USING THIS PRODUCT
    18. DIRECTIONS –CHILDREN’S ROBITUSSIN NIGHTTIME COUGH LONG-ACTING DM
    19. OTHER INFORMATION –CHILDREN’S ROBITUSSIN NIGHTTIME COUGH LONG-ACTING DM
    20. INACTIVE INGREDIENTS –CHILDREN’S ROBITUSSIN NIGHTTIME COUGH LONG-ACTING DM
    21. QUESTIONS OR COMMENTS? –CHILDREN’S ROBITUSSIN NIGHTTIME COUGH LONG-ACTING DM
    22. ADDITIONAL INFORMATION – CHILDREN’S ROBITUSSIN DAY & NIGHT COUGH RELIEF VALUE PACK
    23. PRINCIPAL DISPLAY PANEL – CHILDREN’S ROBITUSSIN DAY & NIGHT COUGH RELIEF VALUE PACK
    24. PRINCIPAL DISPLAY PANEL – CHILDREN’S ROBITUSSIN COUGH & CHEST CONGESTION DM
    25. PRINCIPAL DISPLAY PANEL – CHILDREN’S ROBITUSSIN NIGHTTIM E COUGH DM

Robitussin Day And Night Cough Relief 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 20 Ml)– Children’S Robitussin Cough & Chest Congestion Dm



Dextromethorphan HBr 20 mg

Guaifenesin 200 mg


Purposes– Children’S Robitussin Cough & Chest Congestion Dm



Cough Suppressant

Expectorant


Uses– Children’S Robitussin 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 tubes

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 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 Cough & Chest Congestion Dm



  • each 20 mL contains:sodium 21 mg
  • store at 20-25°C (68-77°F). Do not refrigerate.

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



anhydrous citric acid, carboxymethylcellulose sodium, FD&C blue no. 1, FD&C red no. 40, glycerin, liquid glucose, natural and artificial flavors, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium gluconate, sucralose, xanthan gum


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



call weekdays from 8 AM to 6 PM EST at 1-800-245-1040


Active Ingredients (In Each 10 Ml)– Children’S Robitussin Nighttime Cough Long-Acting Dm



Chlorpheniramine maleate, USP 2 mg

Dextromethorphan HBr, USP 15 mg


Purposes –Children’S Robitussin Nighttime Cough Long-Acting Dm



Antihistamine

Cough suppressant


Uses –Children’S Robitussin Nighttime Cough Long-Acting 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

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 Nighttime Cough Long-Acting 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 under 12 years

    10 mL every 6 hours

    adults and children 12 years and over

    20 mL every 6 hours


Other Information –Children’S Robitussin Nighttime Cough Long-Acting Dm



  • each 10 mL contains:sodium 6 mg
  • store at 20-25°C (68-77°F)

Inactive Ingredients –Children’S Robitussin Nighttime Cough Long-Acting Dm



anhydrous citric acid, FD&C red no. 40, glycerin, lactic acid, natural and artificial flavors, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose


Questions Or Comments? –Children’S Robitussin Nighttime Cough Long-Acting Dm



call weekdays from 8 AM to 6 PM EST at 1-800-245-1040


Additional Information – Children’S Robitussin Day & Night Cough Relief Value Pack



TAMPER-EVIDENT INNER UNITS:

Do Not Use if Tamper-Evident feature on either bottle cap is broken or missing. See individual inner cartons and bottle labels for specific Tamper-Evident features.

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

Children’s Robitussin liquid is specially formulated to provide soothing action, control your child’s cough – plus relieves other cold symptoms.

PARENTS:Learn about teen medicine abuse

www.StopMedicineAbuse.org


Principal Display Panel – Children’S Robitussin Day & Night Cough Relief Value Pack



DAY & NIGHT

COUGH RELIEF

VALUE PACK

Children’s Robitussin

AGES 4 & OVER

Cough & Chest Congestion DM

DEXTROMETHORPHAN HBr

(Cough Suppressant)

GUAIFENESIN

(Expectorant)

Relieves:

  • Chest Congestion/Mucus
  • Cough

    • grapeflavor

    4 FL OZ (118 mL)

    AGES 6 & OVER

    Nighttime Cough Long-Acting DM

    CHLORPHENIRAMINE MALEATE

    (Antihistamine)

    DEXTROMETHORPHAN HBr (Cough Suppressant)

    Relieves:

    • Cough Up to 8 Hours
    • Runny Nose

      • Alcohol-free

      fruit punchflavor

      4 FL OZ (118 mL)


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



Children’s

Robitussin

FOR AGES 4 & OVER

Cough & Chest Congestion DM

DEXTROMETHORPHAN HBr
(Cough Suppressant)

GUAIFENESIN
(Expectorant)

Relieves:

  • Chest Congestion/Mucus
  • Cough

    • BETTER TASTING!*

    Great Grape Taste

    grapeflavor

    4 FL OZ (118 mL)


Principal Display Panel – Children’S Robitussin Nighttim E Cough Dm



Children’s

Robitussin

AGES 6 & OVER

Nighttime Cough DM

Long-Acting

CHLORPHENIRAMINE MALEATE
(Antihistamine)

DEXTROMETHORPHAN HBr
(Cough Suppressant)

Relieves:

  • Cough Up to 8 Hours
  • Runny Nose

    • Alcohol-Free

    fruit punchflavor

    4 FL OZ (118 mL)


* Please review the disclaimer below.