FDA.reportPublic FDA data

Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime

Manufacturer
Haleon US Holdings LLC
Effective date
2024-04-26
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:11:31

Label at a glance#

ProductRobitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure11 sections

Storage and handling

Other information • each 20 mL contains : sodium 22 mg • store at 20-25°C (68-77°F). Do not refrigerate.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each 20 mL)

Acetaminophen 650 mg

Diphenhydramine HCl 25 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/Fever reducer

Antihistamine/Cough suppressant

INDICATIONS & USAGE SECTION

Uses

  • temporarily relieves these symptoms occurring with a cold or flu, hay fever, or other upper respiratory allergies:
    • cough due to minor throat and bronchial irritation
    • minor aches and pains
    • sore throat pain
    • headache
    • runny nose, sneezing, itchy watery eyes
    • itching of the nose and throat
  • temporarily relieves your cough to help you sleep
  • temporarily reduces fever

WARNINGS SECTION

Warnings

Liver warning:

SPL UNCLASSIFIED SECTION

This product contains acetaminophen.

Severe liver damage may occur if you take

  • more than 6 doses in any 24-hour period, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

SPL UNCLASSIFIED SECTION

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning

SPL UNCLASSIFIED SECTION

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

Do not use

OTC - DO NOT USE SECTION

  • to sedate a child or to make a child sleepy
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, emphysema or chronic bronchitis
  • if you have glaucoma or difficulty in urination due to enlargement of prostate gland

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin
  • taking any other pain reliever/fever reducer

When using this product

OTC - WHEN USING SECTION

  • do not use more than directed
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • pain or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION SECTION

Directions

  • do not take more than 6 doses in any 24-hour period
  • do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage.
  • measure only with dosing cup provided
  • keep dosing cup with product
  • mL = milliliter
  • this adult product is not intended for use in children under 12 years of age
Agedose

adults and children

12 years and over

20 mL every 4 hours

children under 12 years

do not use

STORAGE AND HANDLING SECTION

Other information

  • each 20 mL contains: sodium 22 mg
  • store at 20-25°C (68-77°F). Do not refrigerate.

INACTIVE INGREDIENT SECTION

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, glycerin, natural & artificial flavors, natural grade A honey, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium gluconate, sucralose, xanthan gum

OTC - QUESTIONS SECTION

Questions or comments?

call weekdays from 8 AM to 6 PM EST at 1-800-245-1040

Additional information

SPL UNCLASSIFIED SECTION

Packaged with Tamper-Evident bottle cap. Do Not Use if breakable ring is separated or missing.

Distributed by: Haleon, Warren, NJ 07059

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

Trademarks owned or licensed by Haleon.

©2023 Haleon or licensor.

Pat. Info www.productpats.com

Made in Canada

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ADULT
Robitussin

Honey

Nighttime

SEVERE
Cough, Flu +
Sore Throat

ACETAMINOPHEN (Pain Reliever/Fever Reducer)
DIPHENHYDRAMINE HCl (Antihistamine/Cough Suppressant)

MAXIMUM STRENGTH

  • Controls Cough
  • Relieves Runny Nose & Sneezing
  • Relieves Fever & Body Aches

Taste the Real Honey
with Vanilla

CF
NIGHTTIME
MAX

For Ages 12+

8 FL OZ (237 mL)

Robitussin Honey SC F+ST NT 8 oz
Robitussin Honey SC F+ST NT 8 oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2374554acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG in 20 mL Oral SolutionPSN7
2374554acetaminophen 32.5 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML Oral SolutionSCD7
2374554acetaminophen 650 MG / diphenhydramine HCl 25 MG per 20 mL Oral SolutionSY7
2374554APAP 32.5 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML Oral SolutionSY7

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0031-8770-122024-01-30C16284748780-11030e365-209a-111a-e063-dadaa90a10e27decc168-e847-4bbe-910b-26081469406f
0031-8770-182024-01-30C16284748780-11030e365-209a-111a-e063-dadaa90a10e27decc168-e847-4bbe-910b-26081469406f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0031-8770-12Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime118 mL in 1 BOTTLESOLUTION1187
0031-8770-12Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime1 in 1 CARTONSOLUTION17
0031-8770-18Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime1 in 1 CARTONSOLUTION17
0031-8770-18Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime237 mL in 1 BOTTLESOLUTION2377

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0031-8770ROBITUSSIN HONEY SEVERE COUGH, FLU PLUS SORE THROAT NIGHTTIME (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [HALEON US HOLDINGS LLC]7Current NDC, Legacy NDC, 4 package rows20240427_7decc168-e847-4bbe-910b-26081469406f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0031-8770-12ML - Milliliter0031-8770605767f0-4366-477a-bb33-430bd5f1beb612025-12-16
0031-8770-18ML - Milliliter0031-877002530fa9-bdd7-4319-933b-64231ea0066912025-12-16

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0031-87700031-8770-12, 0031-8770-18

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
GLYCERINPDC6A3C0OXIACT
HONEYY9H1V576FHIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SODIUM GLUCONATER6Q3791S76IACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT

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 Honey Severe Cough, Flu Plus Sore Throat NighttimeACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEHaleon US Holdings LLC7decc168-e847-4bbe-910b-26081469406f2024-04-26WarningsExact identifier
ndc (package): 0031-8770-12
ndc (package): 0031-8770-18
ndc (product): 0031-8770
ndc11 (package): 00031877018
ndc11 (package): 00031877012
spl id: e1aff09c-8c75-45af-b83c-71be0cb7309b
spl set id: 7decc168-e847-4bbe-910b-26081469406f

Reported adverse events (FAERS/openFDA)#

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