SCOT-TUSSIN DM MAXIMUM STRENGTH COUGH SUPPRESSANT AND COLD RELIEF- chlorpheniramine maleate and dextromethorphan hydrobromide liquid 
SOCIETAL CDMO SAN DIEGO, 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 DM Maximum Strength Cough Suppressant and Cold Relief

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.
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

  • 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)

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) CHLORPHEN

SCOT-TUSSIN DM MAXIMUM STRENGTH COUGH SUPPRESSANT AND COLD RELIEF 
chlorpheniramine maleate and dextromethorphan hydrobromide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15187-036
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorCHERRY (clear cherry-strawberry flavor) , STRAWBERRY (clear cherry-strawberry flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:15187-036-041 in 1 CARTON01/01/201605/31/2023
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:15187-036-081 in 1 CARTON08/01/201805/31/2023
2237 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/01/201605/31/2023
Labeler - SOCIETAL CDMO SAN DIEGO, LLC (079682716)

Revised: 5/2023
Document Id: fc10a9ab-b0a8-288f-e053-6394a90a1082
Set id: 5bbbb3f0-40bc-4dee-b352-a834a4a09908
Version: 8
Effective Time: 20230519
 
SOCIETAL CDMO SAN DIEGO, LLC