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

Scot-Tussin Original SF Multi-Symptom by

Drug Labeling and Warnings

Scot-Tussin Original SF Multi-Symptom by is a Otc medication manufactured, distributed, or labeled by SCOT-TUSSIN Pharmacal Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

• age: dose
• Adults and childrenover 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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0372-0004
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	160 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	4 mg  in 5 mL
PHENIRAMINE MALEATE (UNII: NYW905655B) (PHENIRAMINE - UNII:134FM9ZZ6M)	PHENIRAMINE MALEATE	4 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	CHERRY, STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0372-0004-04	118 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	12/01/1956

Labeler - SCOT-TUSSIN Pharmacal Co., Inc. (001203918)