Active Ingredients (In Each 20 Ml)– Children’S Robitussin Cough & Chest Congestion Dm
Dextromethorphan HBr 20 mg
Guaifenesin 200 mg
Robitussin Kit
FDA Label NDC 0031-2099
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Robitussin (NDC 0031-2099). 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 ingredients (in each 20 ml)– children’s robitussin cough & chest congestion dm, purposes– children’s robitussin cough & chest congestion dm, uses– children’s robitussin cough & chest congestion dm, do not use, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
- Cough Up to 8 Hours
- Runny Nose
grapeflavor
4 FL OZ (118 mL)
AGES 6 & OVER
Nighttime Cough Long-Acting DM
CHLORPHENIRAMINE MALEATE
(Antihistamine)
DEXTROMETHORPHAN HBr (Cough Suppressant)
Relieves:
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.
