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  5. Label Information: Scot-tussin Original Multi-symptom Cold And Allergy Relief

FDA Label for Scot-tussin Original Multi-symptom Cold And Allergy Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH 5 ML TSP. TEASPOON)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE:
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. IF PREGNANT OR BREAST-FEEDING,
    11. KEEP OUT OF REACH OF CHILDREN.
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. PRINCIPAL DISPLAY PANEL

Scot-tussin Original Multi-symptom Cold And Allergy Relief Product Label

The following document was submitted to the FDA by the labeler of this product Irisys, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient (In Each 5 Ml Tsp. Teaspoon)



Acetaminophen USP 160 mg

Pheniramine Maleate USP 4 mg

Phenylephrine HCI USP 4 mg


Purpose



Pain reliever/Fever reducer

Antihistamine

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

* Please review the disclaimer below.