SCOT-TUSSIN DM MAXIMUM STRENGTH COUGH SUPPRESSANT AND COLD RELIEF- chlorpheniramine maleate and dextromethorphan hydrobromide liquid

Scot-Tussin DM Maximum Strength Cough Suppressant and Cold Relief by

Drug Labeling and Warnings

Scot-Tussin DM Maximum Strength Cough Suppressant and Cold Relief by is a Otc medication manufactured, distributed, or labeled by SOCIETAL CDMO SAN DIEGO, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

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

Chlorpheniramine Maleate USP 2 mg

Purpose

Antihistamine

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

Dextromethorphan HBr. USP 15 mg

Purpose

Cough Suppressant

Uses

• temporarily relieves cough due to minor throat and bronchial irritation as may occur with cold. Quiets and calms a dry cough.
  
• temporarily relieves runny nose and sneezing, itching of the nose and throat, and itchy watery eyes due to upper respiratory symptoms.

Warnings

DO NOT USE THIS PRODUCT TO SEDATE CHILDREN

Do not use:

• more than the recommended dosage.
  
• if you are 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

• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema, or if cough is accompanied by excessive phlegm (mucus).
  
• difficulty in urination due to enlargement of the prostate gland.
  
• glaucoma.
  
• thyroid disease.

When using this product

• may cause drowsiness. Alcohol, sedatives and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. If you are taking sedatives or tranquilizers, consult your doctor before taking this medicine. Use caution when driving a motor vehicle or operating machinery.

Stop use and ask a doctor if

• cough lasts more than seven days, returns or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding,

Do Not Use.

Keep out of reach of children.

In case of accidental overdose get medical help or contact a Poison Control Center right away.

Directions

• 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 children over 12 years old: 2 teaspoons (2 tsp. 10 ml) every 6 hours
• Children under 12 years old: DO NOT USE

Other information

• store at 20° - 25° C (68° - 77° F).
  
• do not refrigerate.
  
• dosage cup provided.

Inactive ingredients

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

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: 15187-036-04
For Diabetics since 1956
SCOT-TUSSIN ®
DM
MAXIMUM STRENGTH
COUGH SUPPRESSANT
& COLD RELIEF
DEXTROMETHORPHAN HBr (Cough Suppressant)
CHLORPHENIRAMINE MALEATE (Antihistamine)
(Cold Relief)
FAST RELIEF OF:
COUGHING, ITCHY EYES, RUNNY NOSE

• FIRST SUGAR & ALCOHOL-FREE
  
• HIGH BLOOD PRESSURE SAFE
  
• LACTOSE & GLUTEN-FREE
  
• SODIUM-FREE
  
• DYE-FREE

LIQUID
4 FL OZ (118 ml)

INGREDIENTS AND APPEARANCE

SCOT-TUSSIN DM MAXIMUM STRENGTH COUGH SUPPRESSANT AND COLD RELIEF 
chlorpheniramine maleate and dextromethorphan hydrobromide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 15187-036
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
METHYLPARABEN (UNII: A2I8C7HI9T)
POTASSIUM BENZOATE (UNII: 763YQN2K7K)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY (clear cherry-strawberry flavor) , STRAWBERRY (clear cherry-strawberry flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 15187-036-04	1 in 1 CARTON	01/01/2016
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 15187-036-08	1 in 1 CARTON	08/01/2018
2		237 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/01/2016

Labeler - IriSys, LLC (079682716)