ROBITUSSIN MAXIMUM STRENGTH SEVERE MULTI-SYMPTOM COUGH COLD FLU- acetaminophen, dextromethorphan hydrobromide, guaifenesin liquid

Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu by

Drug Labeling and Warnings

Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu by is a Otc medication manufactured, distributed, or labeled by Haleon US Holdings LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 20 mL)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Purposes

Pain reliever/Fever reducer

Cough suppressant

Expectorant

INDICATIONS & USAGE

Uses

• temporarily relieves these symptoms occurring with a cold or flu:
  • cough due to minor throat and bronchial irritation
  • minor aches and pains
  • sore throat
  • headache
• temporarily reduces fever
• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive

WARNINGS

Warnings

Liver warning:

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

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

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

• 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.
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if you have

• liver disease
• cough that occurs with too much phlegm (mucus)
• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if you are

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

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.

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

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

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

age	dose
adults and children 12 years and over	20 mL every 4 hours
children under 12 years	do not use

STORAGE AND HANDLING

Other information

• each 20 mL contains:sodium 14 mg
• store at 20-25°C (68-77°F)

INACTIVE INGREDIENT

Inactive ingredients

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

QUESTIONS

Questions or comments?

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

Additional information

Maximum Strength claim based on maximum levels of active ingredients per 4 hour dose.

ADULT

Robitussin

MAXIMUM STRENGTH

SEVERE MULTI-SYMPTOM

Cough Cold + Flu CF MAX

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

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

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.

PRINCIPAL DISPLAY PANEL

ADULT NEW FORMULA HALEON

Robitussin

MAXIMUM STRENGTH

SEVERE
MULTI-SYMPTOM
Cough Cold + Flu

ACETAMINOPHEN (Pain Reliever/Fever Reducer)
DEXTROMETHORPHAN HBr (Cough Suppressant)
GUAIFENESIN (Expectorant)

✓Cough, Sore Throat
✓Head & Body Aches, Fever
✓Chest Congestion
✓Thins & Loosens Mucus

FAST, POWERFUL
multi-symptom relief

CF
MAX

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

62000000207716 Front Carton

INGREDIENTS AND APPEARANCE

ROBITUSSIN MAXIMUM STRENGTH SEVERE MULTI-SYMPTOM COUGH COLD FLU 
acetaminophen, dextromethorphan hydrobromide, guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0031-0100
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg  in 20 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 20 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYL GALLATE (UNII: 8D4SNN7V92)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TRIACETIN (UNII: XHX3C3X673)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	red	Score
Shape		Size
Flavor	RASPBERRY, CHOCOLATE, MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0031-0100-04	1 in 1 CARTON	02/15/2024
1		118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
2	NDC: 0031-0100-08	1 in 1 CARTON	02/15/2024
2		237 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	02/15/2024

Labeler - Haleon US Holdings LLC (079944263)