Label: SCOT-TUSSIN ORIGINAL SF MULTI-SYMPTOM- acetominophen, phenylephrine hydrochloride and pheniramine maleate liquid

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated January 25, 2013

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  • SPL UNCLASSIFIED SECTION

  • 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.
      • minor sore throat.
      • temporarily reduces fever.
      • headaches.
      • nasal congestion.

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

    DO NOT USE THIS PRODUCT TO SEDATE CHILDREN

    Liver warning: This product contains acetaminophne. Severe liver damange 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 monoamie 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 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 broncititis.
    • trouble uritinating 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 old    		2 teaspoons
    (2 tsp. 10ml.)
    every 6 hours
    Children under
    12 years old    		DO NOT USE
  • Other Information

    • each teaspoon (5 ml.) contains:
      Potassium 17.5 mg.
    • Store at 20º – 25º C (68º – 77º F).
    • do not refrigerate.
    • dosage cup provided.
  • Inactive Ingredients

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

  • PRINCIPAL DISPLAY PANEL

    SCOT-
    TUSSIN
    MULTI-SYMPTOM
    COLD & ALLERGY

    SCOT- TUSSIN MULTI-SYMPTOM COLD & ALLERGY

  • INGREDIENTS AND APPEARANCE
    SCOT-TUSSIN ORIGINAL SF MULTI-SYMPTOM 
    acetominophen, phenylephrine hydrochloride and pheniramine maleate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0372-0004
    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)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRY, STRAWBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0372-0004-04118 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34112/01/1956
    Labeler - SCOT-TUSSIN Pharmacal Co., Inc. (001203918)
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