Label: DIABETIC TUSSIN NIGHTTIME COLD AND FLU- acetaminophen, dextromethorphan hbr, and diphenhydramine hcl liquid

  • 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 March 3, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients (in each 10 mL)

    Acetaminophen 650 mg

    Dextromethorphan HBr 20 mg

    Diphenhydramine HCl 25 mg

  • Purposes

    Pain Relief

    Cough Suppressant

    Antihistamine

  • Uses

    temporarily relieves common cold/flu symptoms including:

    • cough due to minor throat and bronchial irritation
    • sore throat
    • headache
    • minor aches and pains
    • muscular aches
    • fever
    • runny nose and sneezing
  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if

    • adults take more than 6 doses in 24 hours, which is the maximum daily amount
    • child takes more than 5 doses in 24 hours, which is the maximum daily amount
    • taken with other drugs containing acetaminophen
    • adult has 3 or more alcoholic drinks everyday while using this product

    Sore throat warning: If sore throat is severe, persists for more than two days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

    Do not use

    Ask a doctor before use if you have

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

    Ask a doctor or pharmacist before use

    if the user is taking the blood thinning drug warfarin, tranquilizers or sedatives.

    When using this product:

    • you may get very drowsy
    • 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 small children

    Stop use and ask a doctor if

    • redness or swelling is present
    • fever gets worse or lasts more than 3 days
    • new symptoms occur
    • pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
    • 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 even if you do not notice any signs or symptoms.

  • Directions

    • take every 4 to 6 hours
    • do not exceed more than 6 doses in 24 hours for adults and children over 12 years of age
    Adults10 mL (2 teaspoons)
    Children under 12 yearsask a doctor
  • Other information

    • Store at room temperature 20-25°C (68-77°F)
  • Inactive ingredients

    Acesulfame potassium, artificial raspberry flavor, hypromellose, menthol, methylparaben, polyethylene glycol, potassium sorbate, propylene glycol, purified water, and sucralose. Citric acid may be used to adjust pH.

  • Questions or comments?

    Call: 1-800-579-8327, serious side effects associated with use of this product may be reported to this number.

  • Package/Label Principal Display Panel

    SUGAR & ALCOHOL FREE!

    Specifically Formulated for Diabetics

    Diabetic Tussin®

    NIGHTTIME

    COLD & FLU

    Acetaminophen (Pain Relief)

    Dextromethorphan HBr (Cough Suppressant)

    Diphenhydramine HCl (Antihistamine)

    Relieves:

    • Cough
    • Sore throat
    • Runny nose & sneezing
    • Minor aches & pains
    • Headache
    • Fever

    Improved Berry Flavor 

    4 FL OZ (118 mL)

    SUGAR & ALCOHOL FREE! Specifically Formulated for Diabetics Diabetic Tussin® NIGHTTIME COLD & FLU Acetaminophen (Pain Relief) Dextromethorphan HBr (Cough Suppressant) Diphenhydramine HCl (Antihistamine) Relieves: • Cough • Sore throat • Runny nose & sneezing • Minor aches & pains • Headache • Fever Improved Berry Flavor 4 FL OZ (118 mL)

  • INGREDIENTS AND APPEARANCE
    DIABETIC TUSSIN NIGHTTIME COLD AND FLU 
    acetaminophen, dextromethorphan hbr, and diphenhydramine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61787-516
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 10 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 10 mL
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    RASPBERRY (UNII: 4N14V5R27W)  
    WATER (UNII: 059QF0KO0R)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorRASPBERRY (artificial raspberry flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61787-516-041 in 1 CARTON02/01/2020
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/01/2020
    Labeler - MEDTECH PRODUCTS INC (114707784)
    Establishment
    NameAddressID/FEIBusiness Operations
    Akorn Operating Company LLC (dba Akorn)117696873manufacture(61787-516)
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