FDA.reportPublic FDA data

Robitussin Direct Stuffy Nose

Manufacturer
Haleon US Holdings LLC
Effective date
2024-04-12
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:05:57

Label at a glance#

ProductRobitussin Direct Stuffy Nose
Active ingredientPHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections

Storage and handling

Other information • store at 20-25°C (68-77°F)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Phenylephrine HCl 10 mg

OTC - PURPOSE SECTION

Purpose

Nasal decongestant

INDICATIONS & USAGE SECTION

Uses

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

WARNINGS SECTION

Warnings

Do not use

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

  • 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.

OTC - WHEN USING SECTION

Stop Use and ask a doctor if

OTC - STOP USE SECTION

  • 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

DOSAGE & ADMINISTRATION SECTION

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 SECTION

Other information

  • store at 20-25°C (68-77°F)

INACTIVE INGREDIENT SECTION

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 SECTION

Questions or comments?

Call weekdays from 9 AM to 5 PM EST at 1-800-245-1040

Additional Information

SPL UNCLASSIFIED SECTION

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

PACKAGE LABEL.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 18 caplets

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0031-93050031-9305-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
DEXTROSE MONOHYDRATELX22YL083GIACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
FD&C RED NO. 40WZB9127XOAIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
5a62a76b-6576-4406-a39b-8af99f3ebce97ac1ce3a-efe2-4773-9ed9-dcc49c6e651e2024-04-12WarningsExact identifier
spl id: 5a62a76b-6576-4406-a39b-8af99f3ebce9
spl set id: 7ac1ce3a-efe2-4773-9ed9-dcc49c6e651e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.