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

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.

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Scot-Tussin Original Multi-Symptom Cold and Allergy Relief

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

Warnings

DO NOT USE THIS PRODUCT TO SEDATE CHILDREN

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

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

       

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

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)

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)

Revised: 10/2015
Document Id: 493ea01e-aa58-4f68-909e-031defb2338e
Set id: ce11862b-24c6-4d51-87a9-930858a47de5
Version: 2
Effective Time: 20151015
 
IriSys, LLC