FDA.reportPublic FDA data

Robitussin Medi-Soothers

Manufacturer
Haleon US Holdings LLC
Effective date
2024-04-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:10:46

Label at a glance#

ProductRobitussin Medi-Soothers
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, MENTHOL, UNSPECIFIED FORM
Label structure10 sections

Indications and uses

temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold occasional minor irritation, pain, sore mouth, and sore throat

Dosage and administration

adults and children 12 years of age and older: take 2 lozenges (one immediately after the other) every 4 hours as needed. Allow each lozenge to dissolve slowly in the mouth. do not take more than 12 lozenges in any 24-hour period, or as directed by a doctor children under 12 years of age: do not use

Label contents#

Full prescribing information#

Active ingredients (in each lozenge)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 5 mg

Menthol 5 mg

Purposes

OTC - PURPOSE SECTION

Cough suppressant

Oral anesthetic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves

  • cough due to minor throat and bronchial irritation as may occur with the common cold
  • occasional minor irritation, pain, sore mouth, and sore throat

Warnings

WARNINGS SECTION

Sore throat warning

WARNINGS SECTION

  • if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly

Do Not Use

OTC - DO NOT USE SECTION

  • if you are now taking 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

  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough that occurs with too much phlegm (mucus)

Stop use and ask a doctor or dentist if

OTC - STOP USE SECTION

  • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
  • sore mouth symptoms do not improve in 7 days
  • irritation, pain, or redness persists or worsens

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years of age and older: take 2 lozenges (one immediately after the other) every 4 hours as needed. Allow each lozenge to dissolve slowly in the mouth.
  • do not take more than 12 lozenges in any 24-hour period, or as directed by a doctor
  • children under 12 years of age: do not use

Other information

SPL UNCLASSIFIED SECTION

  • store at 20°-25°C (68°-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn syrup, elderberry juice concentrate, glycerin, natural flavors, propylene glycol, purified water, soy lecithin, sucralose, sucrose

Questions or comments?

OTC - QUESTIONS SECTION

call weekdays from 8 am to 6 pm EST at 1-800-245-1040

Additional Information

SPL UNCLASSIFIED SECTION

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Keep carton for complete information.

Do not use if blister is broken or damaged.

Distributed by: Haleon, Warren, NJ 07059

Trademarks owned or licensed by Haleon.

©2023 Haleon or licensor.

For more recent product information, visit www.robitussin.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW! ADULT

Robitussin

Elderberry

MEDI-SOOTHERS

DEXTROMETHORPHAN HBr (Cough Suppressant) 5 mg

Menthol (Oral Anesthetic) 5 mg

Cough + Sore Throat

Taste the Real Elderberry

  • Relieves Cough for up to 4 HOURS
  • Relieves Sore Throat Pain

Elderberry Flavor

Actual Size

For Ages 12+

16 MEDICATED LOZENGES

202559 Front Carton

Robitussin Medi-Soothers Elderberry 16 Medicated LozengesRobitussin Medi-Soothers Elderberry 16 Medicated Lozenges

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1301246dextromethorphan HBr 5 MG / menthol 5 MG Oral LozengePSN2
1301246dextromethorphan hydrobromide 5 MG / menthol 5 MG Oral LozengeSCD2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0031-9307-01Robitussin Medi-Soothers16 in 1 BLISTER PACKLOZENGE162

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0031-9307ROBITUSSIN MEDI-SOOTHERS (DEXTROMETHORPHAN HYDROBROMIDE, MENTHOL) LOZENGE [HALEON US HOLDINGS LLC]2Current NDC, 1 package rows20240408_4c3d57e3-e40b-41ca-b44b-5f4c5f4dbae5.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0031-93070031-9307-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
CORN SYRUP9G5L16BK6NIACT
EUROPEAN ELDERBERRY JUICEZ4IFJ0AK1EIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
SUCRALOSE96K6UQ3ZD4IACT
SUCROSEC151H8M554IACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB

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
Robitussin Medi-SoothersDEXTROMETHORPHAN HYDROBROMIDE, MENTHOLHaleon US Holdings LLC4c3d57e3-e40b-41ca-b44b-5f4c5f4dbae52024-04-06WarningsExact identifier
ndc (package): 0031-9307-01
ndc (product): 0031-9307
ndc11 (package): 00031930701
spl id: 1571df1a-4352-e93d-e063-6294a90a576a
spl set id: 4c3d57e3-e40b-41ca-b44b-5f4c5f4dbae5

Reported adverse events (FAERS/openFDA)#

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