Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttime

Manufacturer
Haleon US Holdings LLC
Effective date
2024-01-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:08:38

Label at a glance#

ProductRobitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttime
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Storage and handling

Other information each 20 mL contains: sodium 12 mg store at 20-25°C (68-77°F)

Label contents#

Full prescribing information#

Active ingredients (in each 20 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 650 mg

Diphenhydramine HCl 25 mg

Purposes

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 respiratory allergies:
    • cough due to minor throat and bronchial irritation
    • headache
    • sore throat
    • minor aches and pains
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat
  • temporarily relieves your cough to help you rest
  • 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.

OTC - DO NOT USE SECTION

Do not use

  • 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 drug containing diphenhydramine, even one used on skin

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • liver disease
  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

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

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • 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 12 mg
  • store at 20-25°C (68-77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients

anhydrous citric acid, artificial flavor, edetate disodium, FD&C red no. 40, glycerin, menthol, polyethylene glycol, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

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

Do Not Use if breakable ring on bottle cap is separated or missing.

ADULT

Robitussin

MAXIMUM STRENGTH

SEVERE MULTI-SYMPTOM

Cough Cold + Flu CFNIGHTTIME MAX

Distributed by: Haleon, Warren, NJ 07059

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

Trademarks owned or licensed by Haleon.

Pat. Info www.productpats.com

©2023 Haleon or licensor. Made in Canada

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ADULT NEW FORMULA HALEON

Robitussin

MAXIMUM STRENGTH

SEVERE
MULTI-SYMPTOM
Cough Cold + Flu

Nighttime

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

Relieves Cough to Help You Rest

✓Cough, Sore Throat
✓Head & Body Aches, Fever
✓Runny Nose, Sneezing

FAST, POWERFUL
multi-symptom relief

CF
NIGHTTIME
MAX

For Ages 12 & Over
4 FL OZ (237 mL)

207723 Front Carton

Robitussin Severe Multi-Symptom CC+F NT 4 fl oz (118 mL)
Robitussin Severe Multi-Symptom CC+F NT 4 fl oz (118 mL)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2374554acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG in 20 mL Oral SolutionPSN1
2374554acetaminophen 32.5 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML Oral SolutionSCD1
2374554acetaminophen 650 MG / diphenhydramine HCl 25 MG per 20 mL Oral SolutionSY1
2374554APAP 32.5 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML Oral SolutionSY1

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
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0031-0101-04Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttime1 in 1 CARTONLIQUID11
0031-0101-04Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttime118 mL in 1 BOTTLELIQUID1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0031-0101ROBITUSSIN MAXIMUM STRENGTH SEVERE MULTI-SYMPTOM COUGH COLD FLU NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) LIQUID [HALEON US HOLDINGS LLC]1Current NDC, 2 package rows20240215_721bfee2-0d3d-4d8b-beee-1ea83064d1c8.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0031-01010031-0101-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

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 Maximum Strength Severe Multi-Symptom Cough Cold Flu NighttimeACETAMINOPHEN, DIPHENHYDRAMINE HCLHaleon US Holdings LLC721bfee2-0d3d-4d8b-beee-1ea83064d1c82024-01-23WarningsExact identifier
ndc (package): 0031-0101-04
ndc (product): 0031-0101
ndc11 (package): 00031010104
spl id: 0f9df094-b106-76fc-e063-6294a90a6a18
spl set id: 721bfee2-0d3d-4d8b-beee-1ea83064d1c8

Reported adverse events (FAERS/openFDA)#

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