FDA.reportPublic FDA data

Robitussin Direct Runny 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 Runny Nose
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Storage and handling

Other information • each tablet contains: calcium 30 mg • store at 20-25°C (68-77°F)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Diphenhydramine HCI 25 mg

OTC - PURPOSE SECTION

Purpose

Antihistamine

INDICATIONS & USAGE SECTION

Uses

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • runny nose
  • itchy, watery eyes
  • sneezing
  • itching of the nose or throat
  • temporarily relieves these symptoms due to the common cold:
  • runny nose
  • sneezing

WARNINGS SECTION

Warnings

Do not use

OTC - DO NOT USE SECTION

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • marked drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • use caution when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
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 directed
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 times in 24 hours

adults and children 12 years and over

1 to 2 tablets

Children 6 to under 12 years

1 tablet

children under 6 years

do not use

STORAGE AND HANDLING SECTION

Other information

  • each tablet contains: calcium 30 mg
  • store at 20-25°C (68-77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients

D&C red no. 27 aluminum lake, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch,

silicon dioxide, stearic acid, talc, 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

Runny Nose
Diphenhydramine HCl

(Antihistamine)

direct

Actual size

18
Tablets
L-0630-329-44-UPC_ORG Front Label

Robitussin Direct Runny Nose 18 caplets
Robitussin Direct Runny Nose 18 caplets

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0031-93040031-9304-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
D&C RED NO. 27 ALUMINUM LAKEZK64F7XSTXIACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
STARCH, CORNO8232NY3SJIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
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
f466be59-73f9-4d0a-9b6e-866850bda6ad7a049de2-8f24-4cb3-8b30-331db00a455e2024-04-12WarningsExact identifier
spl id: f466be59-73f9-4d0a-9b6e-866850bda6ad
spl set id: 7a049de2-8f24-4cb3-8b30-331db00a455e

Reported adverse events (FAERS/openFDA)#

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