FDA Label for Robitussin Long-acting Cough Soft Chews
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- ADDITIONAL INFORMATION
- PRINCIPAL DISPLAY PANEL
Robitussin Long-acting Cough Soft Chews 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.
Otc - Active Ingredient
Active ingredient (in each chewable tablet)
Dextromethorphan equivalent to dextromethorphan HBr 15 mg
Otc - Purpose
Purpose
Cough suppressant
Indications & Usage
Use
- temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
Warnings
Warnings
Otc - Do Not Use
Do not useif 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, or emphysema
Otc - Stop Use
Stop use and ask a doctor ifcough 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 4 doses (8 chewable tablets) in any 24-hour period
- this adult product is not intended for use in children under 12 years of age
| age | dose | |
|---|---|---|
adults and children 12 years and over | take 2 chewable tablets every 6 to 8 hours, as needed | |
children under 12 years | do not use |
Storage And Handling
Other information
- each chewable tablet contains:potassium 10 mg, sodium 6 mg
- store at a controlled room temperature 20-25°C (68-77°F)
Inactive Ingredient
Inactive ingredients
carboxymethylcellulose calcium, carnauba wax, corn syrup solids, crospovidone, FD&C red no. 40, glycerin, mannitol, natural and artificial flavors, pregelatinized starch, simethicone, sodium gluconate, sorbitol, sorbitol solution, sucralose, sucrose, whole dry milk
Otc - Questions
Questions or comments?
call weekdays from 8 AM to 6 PM EST at 1-800-245-1040
Additional Information
Do Not Use if seal under bottle cap imprinted with
“SEALED for YOUR PROTECTION” is broken or missing.
PARENTS:
Learn about teen medicine abuse
www.StopMedicineabuse.org
Distributed by: Haleon, Warren, NJ 07059
Trademarks are owned by or licensed to the Haleon group of companies.
Pat. Info www.productpats.com
©2023 Haleon group of companies or its licensor.
For most recent product information, visit www.robitussin.com
Principal Display Panel
NEW! ADULT HALEON
Robitussin
Long-Acting Cough
Soft CHEWS
DEXTROMETHORPHAN HBr 15 mg
(Cough Suppressant)
FAST relief ANYWHERE
UP TO 8HRCOUGH RELIEF
Chew tablets completely before swallowing
Berry flavor
10 CHEWABLE TABLETS
208802 Front Label
* Please review the disclaimer below.