Label: ROBITUSSIN MAXIMUM STRENGTH SEVERE COUGH PLUS SORE THROAT- acetaminophen, dextromethorphan hydrobromide liquid

  • NDC Code(s): 0031-8750-12, 0031-8750-18
  • Packager: Richmond Division of Wyeth
  • Category: HUMAN OTC DRUG LABEL

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.

Drug Label Information

Updated April 11, 2017

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredients (in each 20 ml) Purposes
    Acetaminophen, USP 650 mg Pain reliever/Fever reducer
    Dextromethorphan HBr, USP 20 mg Cough suppressant
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  • 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 pain
      • headache
    • temporarily reduces fever
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  • 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.

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  • 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
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  • Other information

    • each 20 ml contains: sodium 13 mg
    • store at 20-25°C (68-77°F). Do not refrigerate.
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  • 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

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  • 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

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  • SPL UNCLASSIFIED SECTION

    Distributed by: Pfizer, Madison, NJ 07940 USA

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  • 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
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  • 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
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  • INGREDIENTS AND APPEARANCE
    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)
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