ROBITUSSIN MAXIMUM STRENGTH SEVERE COUGH PLUS SORE THROAT- acetaminophen, dextromethorphan hydrobromide liquid 
Richmond Division of Wyeth

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.

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Robitussin® Maximum Strength Severe Cough Plus Sore Throat

Drug Facts

Active ingredients (in each 20 ml) Purposes
Acetaminophen, USP 650 mg Pain reliever/Fever reducer
Dextromethorphan HBr, USP 20 mg Cough suppressant

Uses

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, 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

When using this product do not use more than directed.

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.

Directions

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

Other information

Inactive ingredients

anhydrous citric acid, FD&C red no. 40, glycerin, menthol, natural & artificial flavor, polyethylene glycol, polysorbate 80, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, 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
Cough +
Sore Throat

CF
MAX

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

Strong Cooling Liquid
Non-Drowsy

4 FL OZ (118 ml)

PRINCIPAL DISPLAY PANEL - 118 ml Bottle Label

PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton

New

ADULT
Robitussin
®

MAXIMUM STRENGTH

SEVERE
Cough +
Sore Throat

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

Relieves:
✓ Cough
✓ Sore Throat Pain

Strong Cooling Liquid
Non-Drowsy

POWERFUL
SORE THROAT
Relief

CF
MAX

For Ages 12 & Over

4 FL OZ (118 ml)

PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton
ROBITUSSIN MAXIMUM STRENGTH SEVERE COUGH PLUS SORE THROAT 
acetaminophen, dextromethorphan hydrobromide liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0031-8750
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
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Color RED Score     
Shape Size
Flavor MINT Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0031-8750-12 1 in 1 CARTON 04/10/2017
1 118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2 NDC:0031-8750-18 1 in 1 CARTON 04/10/2017
2 237 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Final part341 04/10/2017
Labeler - Richmond Division of Wyeth (829390835)
Registrant - Pfizer Inc (113480771)
Establishment
Name Address ID/FEI Business Operations
Pfizer Canada Inc. 246770197 ANALYSIS(0031-8750) , LABEL(0031-8750) , MANUFACTURE(0031-8750) , PACK(0031-8750)

Revised: 4/2017
Document Id: 8a2f886c-5fac-42e6-a47e-d036ada6afff
Set id: 6a6f5da8-6433-4284-8df7-2d5b099b74dc
Version: 1
Effective Time: 20170411
 
Richmond Division of Wyeth