Active Ingredients (In Each 10 Ml) – Children’S Robitussin Honey Cough & Chest Congestion Dm
Dextromethorphan HBr, USP 10 mg
Guaifenesin, USP 100 mg
Robitussin Kit
FDA Label NDC 0031-2102
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 0031-2102). 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 10 ml) – children’s robitussin honey cough & chest congestion dm, purposes – children’s robitussin honey cough & chest congestion dm, uses – children’s robitussin honey 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 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)
* Please review the disclaimer below.
