SCOT-TUSSIN SENIOR MAXIMUM STRENGTH COUGH SUPPRESSANT AND EXPECTORANT- dextromethorphan hydrobromide and guaifenesin liquid

Scot-Tussin Senior Maximum Strength Cough Suppressant and Expectorant by

Drug Labeling and Warnings

Scot-Tussin Senior Maximum Strength Cough Suppressant and Expectorant 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 Fact

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

Dextromethorphan HBr. USP 15 mg

Purpose

Cough Suppressant

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

Guaifenesin USP 200mg

Purpose

Expectorant

Uses

• temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold. Quiets and calms a dry cough.
  
• helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive thereby relieving chest congestion.

Warnings

*Phenylketoneurics: Contains Phenylalanine.

Do not use:

• more than the recommended dosage.
  
• if drowsiness occurs, do not drive or operate machinery.
  
• 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

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

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

• each teaspoon contains Phenylalanine 7.5 mg.
  
• store at 20°-25° C (68°-77° F).
  
• do not refrigerate.
  
• dosage cup provided.

Inactive ingredients

aspartame* (see warning), benzoic acid, citric acid, glycerin, hydroxypropylmethylcellulose, menthol, menthyl-paraben, clear peppermint stick flavor, 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: 15187-050-04
For Diabetics since 1956
SCOT-TUSSIN ®
SENIOR
MAXIMUM STRENGTH
COUGH SUPPRESSANT
& EXPECTORANT
DEXTROMETHORPHAN HBr (Cough Suppressant)
GUAIFENESIN (Expectorant)
FAST RELIEF OF:
COUGHING &
CHEST CONGESTION

• 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 SENIOR MAXIMUM STRENGTH COUGH SUPPRESSANT AND EXPECTORANT 
dextromethorphan hydrobromide and guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 15187-050
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ASPARTAME (UNII: Z0H242BBR1)
BENZOIC ACID (UNII: 8SKN0B0MIM)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	PEPPERMINT (clear peppermint stick flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 15187-050-04	1 in 1 CARTON	01/01/2016
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 15187-050-08	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)