FDA Label for Robitussin Direct Stuffy Nose
View Indications, Usage & Precautions
Robitussin Direct Stuffy Nose 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 tablet)
Phenylephrine HCl 10 mg
Otc - Purpose
Purpose
Nasal decongestant
Indications & Usage
Uses
• temporarily relieves sinus congestion and pressure• temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
Warnings
Warnings
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
• heart disease• high blood pressure• thyroid disease• diabetes• trouble urinating due to an enlarged prostate gland
Stop Use And Ask A Doctor If
• nervousness, dizziness, or sleeplessness occur• symptoms do not improve within 7 days or occur with fever
Dosage & Administration
Directions
• do not take more than 6 tablets in 24 hours• this adult product is not intended for use in children under 12 years of age
adults and children 12 years and over | take 1 tablet every 4 hours |
children under 12 years | do not use |
Storage And Handling
Other information
• store at 20-25°C (68-77°F)
Inactive Ingredient
Inactive ingredients
carboxymethylcellulose sodium, croscarmellose sodium, dextrose monohydrate, dibasic calcium
phosphate dihydrate, FD&C red no. 40, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide, sodium citrate, soy lecithin, titanium dioxide
Otc - Questions
Questions or comments?
Call weekdays from 9 AM to 5 PM EST at 1-800-245-1040
Additional Information
Do not use if safety seal under cap printed with “Sealed for Your Protection” is broken or missing.
Lift Here for More Drug Facts
Distributed by: GSK Consumer Healthcare, Warren, NJ 07059
visit www.robitussin.com
Trademarks owned or licensed by GSK.
©2022 GSK or licensor.
Made in China
Principal Display Panel
NEW
Robitussin
Stuffy Nose
Phenylephrine HCl
(Nasal Decongestant)
direct
Actual size
18
Tablets
L-0630-453-44-UPC_ORG Front Label
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