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Robitussin Severe Multi-Symptom Cough Cold Flu

Dosage form: liquid
Ingredients: ACETAMINOPHEN 650mg in 20mL, DEXTROMETHORPHAN HYDROBROMIDE 20mg in 20mL, GUAIFENESIN 400mg in 20mL, PHENYLEPHRINE HYDROCHLORIDE 10mg in 20mL
Labeler: Richmond Division of Wyeth
NDC Code: 0031-8751

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Robitussin® Severe Multi-Symptom Cough Cold Flu

Drug Facts

Active ingredients (in each 20 ml)Purposes
Acetaminophen, USP 650 mgPain reliever/Fever reducer
Dextromethorphan HBr, USP 20 mgCough suppressant
Guaifenesin, USP 400 mgExpectorant
Phenylephrine HCl, USP 10 mgNasal decongestant

Uses

  • temporarily relieves these symptoms occurring with a cold or flu:
    • cough due to minor throat and bronchial irritation
    • nasal congestion
    • sinus congestion and pressure
    • 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

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
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • 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 oral nasal decongestant or stimulant
  • taking any other pain reliever/fever reducer

When using this product do not use more than directed

Stop use and ask a doctor if

  • you get nervous, dizzy, or sleepless
  • pain, cough, or nasal congestion 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.

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 over20 ml every 4 hours
children under 12 yearsdo not use

Other information

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

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 or comments?

call weekdays from 9 AM to 5 PM EST at 1-800-762-4675

Made in Canada

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

Distributed by: Pfizer, Madison, NJ 07940 USA

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

ADULT

Robitussin®

MAXIMUM STRENGTH

SEVERE
Multi-Symptom
Cough Cold + Flu
CF

MAX

ACETAMINOPHEN (Pain Reliever/Fever Reducer)
DEXTROMETHORPHAN HBr (Cough Suppressant)
GUAIFENESIN (Expectorant)
PHENYLEPHRINE HCl (Nasal Decongestant)

4 FL OZ (118 ml)

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

ADULT
NEW!

Robitussin®

MAXIMUM STRENGTH

SEVERE
Multi-Symptom
Cough Cold + Flu

ACETAMINOPHEN (Pain Reliever/Fever Reducer)
DEXTROMETHORPHAN HBr (Cough Suppressant)
GUAIFENESIN (Expectorant)
PHENYLEPHRINE HCl (Nasal Decongestant)

Relieves:
✓Cough, Sore Throat
✓Body Aches, Fever
✓Nasal Congestion
✓Chest Congestion

Non-Drowsy

Better Taste!
Treats More
Symptoms*
CF
MAX

For Ages 12 & Over
4 FL OZ (118 ml)

ROBITUSSIN SEVERE MULTI-SYMPTOM COUGH COLD FLU 
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-8751
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN650 mg  in 20 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN400 mg  in 20 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM 
FD&C RED NO. 40 
GLYCERIN 
MENTHOL, UNSPECIFIED FORM 
POLYETHYLENE GLYCOL, UNSPECIFIED 
PROPYL GALLATE 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SODIUM CITRATE, UNSPECIFIED FORM 
SORBITOL 
SUCRALOSE 
TRIACETIN 
XANTHAN GUM 
ANHYDROUS CITRIC ACID 
Product Characteristics
ColorREDScore    
ShapeSize
FlavorRASPBERRY, CHOCOLATE, MINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0031-8751-121 BOTTLE in 1 CARTON
1118 mL in 1 BOTTLE
2NDC:0031-8751-181 BOTTLE in 1 CARTON
2237 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/01/2015
Labeler - Richmond Division of Wyeth (829390835)
Registrant - Pfizer Inc (113480771)
Establishment
NameAddressID/FEIOperations
Pfizer Canada Inc.246770197ANALYSIS(0031-8751), LABEL(0031-8751), MANUFACTURE(0031-8751), PACK(0031-8751)

Revised: 06/2016
 
Richmond Division of Wyeth

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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