ROBITUSSIN DIRECT STUFFY NOSE- phenylephrine hcl tablet, coated 
Haleon US Holdings LLC

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Drug Facts

Active ingredient (in each tablet)

Phenylephrine HCl 10 mg

Purpose

Nasal decongestant

Uses

temporarily relieves sinus congestion and pressure
temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

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

When using this product do not use more than directed.

Stop Use and ask a doctor if

nervousness, dizziness, or sleeplessness occur
symptoms do not improve within 7 days or occur with fever

If pregnant or breast-feeding, 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

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

Other information

store at 20-25°C (68-77°F)

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

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

Robitussin Direct Stuffy Nose 18 caplets
ROBITUSSIN DIRECT STUFFY NOSE 
phenylephrine hcl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-9305
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize7mm
FlavorImprint Code 44;453
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0031-9305-0118 in 1 BOTTLE; Type 0: Not a Combination Product07/15/202210/15/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01207/15/202210/15/2024
Labeler - Haleon US Holdings LLC (079944263)

Revised: 4/2024
Document Id: 5a62a76b-6576-4406-a39b-8af99f3ebce9
Set id: 7ac1ce3a-efe2-4773-9ed9-dcc49c6e651e
Version: 4
Effective Time: 20240412
 
Haleon US Holdings LLC