Active Ingredients (In Each 20 Ml)
Dextromethorphan HBr, USP 20 mg
Guaifenesin, USP 400 mg
Childrens Robitussin Elderberry Cough And Chest Congestion Dm Solution
FDA Label NDC 0031-2098
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 Childrens Robitussin Elderberry Cough And Chest Congestion Dm (NDC 0031-2098). 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), purposes, indications & usage, warnings, otc - do not use, ask a doctor before use if you have, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
Cough suppressant
Expectorant
Indications & Usage
Uses
▪ 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
Warnings
Warnings
Otc - Do Not Use
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.
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.
Otc - Stop Use
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
▪ 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 |
Storage And Handling
Other information
▪ each 20 ml contains: potassium 5 mg,sodium 20 mg▪ store at 20-25°C (68-77°F). Do not refrigerate.
Inactive Ingredient
Inactive ingredients
anhydrous citric acid, black elderberry juice concentrate (for flavor), carboxymethylcellulose sodium, glycerin, liquid glucose, maltodextrin, natural and artificial flavors, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium gluconate, sucralose, xanthan gum, zinc gluconate
Otc - Questions
Questions or comments?
call weekdays from 9 AM to 5 PM EST at 1-800-245-1040
Additional Information
Distributed by: GSK Consumer Healthcare, Warren, NJ 07059
For most recent product information, visit www.robitussin.com
Trademarks owned or licensed by GSK
@2021 GSK or licensor
Should be 18 or older to purchase
PARENTS:
Learn about teen medicine abuse
Packaged with Tamper-Evident bottle cap.
Do Not Use if breakable ring is separated or missing.
Principal Display Panel
NDC 0031-2098-01
Children’s
NEW!
Robitussin
Elderberry
Cough & Chest
Congestion DM
DEXTROMETHORPHAN HBr (Cough Suppressant)
GUAIFENESIN (Expectorant)
NON-DROWSY
✓ Controls Cough✓ Relieves Chest Congestion✓ Thins & Loosens Mucus
Taste the
Real Elderberry
4 FL OZ (118 ml)
For Ages 4+
PAA163291 Front Carton
Robi Elderberry Ccc 118 mL Front Carton (Image 01)
* Please review the disclaimer below.
