Label: SCOT-TUSSIN ORIGINAL MULTI-SYMPTOM COLD AND ALLERGY RELIEF- acetominophen, phenylephrine hydrochloride and pheniramine maleate liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 October 15, 2015

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 5 mL tsp. teaspoon)

    Acetaminophen USP 160 mg

  • Purpose

    Pain reliever/Fever reducer

  • Active ingredient (in each 5 mL tsp. teaspoon)

    Pheniramine Maleate USP 4 mg

  • Purpose

    Antihistamine

  • Active ingredient (in each 5 mL tsp. teaspoon)

    Phenylephrine HCI USP 4 mg

  • Purpose

    Decongestant

  • Uses

    • temporarily relieves these symptoms due to a cold:
      • minor aches and pains.
      • headaches.
      • minor sore throat.
      • nasal congestion.
      • temporarily reduces fever.

    • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
      • runny nose.
      • sneezing.
      • itchy nose and throat.
      • itchy, watery eyes.
  • Warnings

    DO NOT USE THIS PRODUCT TO SEDATE CHILDREN

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

    • more than 4 doses in 24 hours, which is the maximum daily amount.
    • with other drugs containing acetaminophen.
    • 3 or more alcoholic drinks every day while using this product.

    Do not use:

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

    Ask a doctor before use if you have

    • liver disease.
    • heart disease.
    • high blood pressure.
    • thyroid disease.
    • diabetes.
    • glaucoma.
    • a breathing problem such as emphysema, asthma or chronic bronchitis.
    • trouble urinating due to an enlarged prostate gland.

    Ask a doctor or pharmacist before use if you are

    • taking sedatives or tranquilizers.
    • taking the blood thinning drug warfarin.

    When using this product

    • do not use more than directed.
    • avoid alcoholic drinks.
    • drowsiness may occur.
    • alcohol, sedatives and tranquilizers may increase drowsiness.
    • be careful when driving a motor vehicle or operating machinery.
    • excitability may occur, especially in children.

    Stop use and ask a doctor if

    • you get nervous, dizzy or sleepless.
    • pain 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.
    • sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting.

    If pregnant or breast-feeding,

    Do Not Use.

    Keep out of reach of children.

    In case of overdose get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

  • Directions

    • do not use more than directed – see Liver warning.
    • follow Dosage Chart.
    • do not take more than 4 doses in any 24 hour period.
    • this product is not intended for use in children under 12 years of age.

           

    agedose
    Adults and children over 12 years old2 teaspoons (2 tsp. 10 mL) every 6 hours
    Children under 12 years oldDO NOT USE

    Other information

    • each teaspoon (5 mL) contains: Potassium 17.5 mg.
    • store at 20°- 25° C (68°-77°F).
    • do not refrigerate.
    • dosage cup provided
  • Inactive ingredients

    ammonium glycyrrhizate, citric acid, clear cherry-strawberry flavor, glycerin, hydroxyethylcelluose, methyl-paraben, polyethylene glycol, potassium benzoate, potassium citrate, propyl-paraben, purified water, sucralose.

    Distributed by:
    IriSys, LLC
    San Diego, CA 92121 U.S.A.
    Questions? 1-800-638-7268
    www.scot-tussin.com
    ®TM Reg. US Patent Office No. 657, 674

  • PRINCIPAL DISPLAY PANEL

    SUGAR-FREE
    ADULT
    NDC 15187-004-04
    For Diabetics since 1956
    SCOT-TUSSIN®
    ORIGINAL
    MULTI-SYMPTOM
    COLD & ALLERGY RELIEF
    ACETAMINOPHEN (pain reliever, fever reducer)
    PHENIRAMINE MALEATE (antihistamine)
    PHENYLEPHRINE HCI (nasal decongestant)

    FAST RELIEF OF:
    PAIN, FEVER, STUFFY HEAD,
    SINUS CONGESTION, ITCHY,
    RUNNY NOSE

    • FIRST SUGAR & ALCOHOL-FREE
    • LACTOSE & GLUTEN-FREE
    • SODIUM-FREE
    • DYE-FREE

    LIQUID
    4 FL OZ (118 ml)

    PRINCIPAL DISPLAY PANEL SUGAR-FREE ADULT NDC 15187-004-04 For Diabetics since 1956 SCOT-TUSSIN® ORIGINAL MULTI-SYMPTOM COLD & ALLERGY RELIEF ACETAMINOPHEN (pain reliever, fever reducer) PHENIRAMINE MALEATE (antihistamine) PHENYLEPHRINE HCI (nasal decongestant) FAST RELIEF OF: PAIN, FEVER, STUFFY HEAD, SINUS CONGESTION, ITCHY, RUNNY NOSE • FIRST SUGAR & ALCOHOL-FREE • LACTOSE & GLUTEN-FREE • SODIUM-FREE • DYE-FREE LIQUID 4 FL OZ (118 ml)

  • INGREDIENTS AND APPEARANCE
    SCOT-TUSSIN ORIGINAL MULTI-SYMPTOM COLD AND ALLERGY RELIEF 
    acetominophen, phenylephrine hydrochloride and pheniramine maleate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15187-004
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE4 mg  in 5 mL
    PHENIRAMINE MALEATE (UNII: NYW905655B) (PHENIRAMINE - UNII:134FM9ZZ6M) PHENIRAMINE MALEATE4 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POTASSIUM BENZOATE (UNII: 763YQN2K7K)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRY (clear cherry-strawberry flavor) , STRAWBERRY (clear cherry-strawberry flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15187-004-041 in 1 CARTON
    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 FINALpart34101/01/2016
    Labeler - IriSys, LLC (079682716)
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