FDA.reportPublic FDA data

Scot-Tussin DM Maximum Strength Cough Suppressant and Cold Relief

Manufacturer
SOCIETAL CDMO SAN DIEGO, LLC
Effective date
2023-05-19
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 21:31:07

Label at a glance#

ProductScot-Tussin DM Maximum Strength Cough Suppressant and Cold Relief
Active ingredientCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE
Label structure10 sections

Indications and 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.

Dosage and administration

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

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

OTC - ACTIVE INGREDIENT SECTION

Chlorpheniramine Maleate USP 2 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

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

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr. USP 15 mg

Purpose

OTC - PURPOSE SECTION

Cough Suppressant

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

DO NOT USE THIS PRODUCT TO SEDATE CHILDREN

Do not use:

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • 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

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

Do Not Use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.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 S...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 S...

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
15187-036-04ML - Milliliter15187-036c6b62282-cb7d-47ae-bf21-2f9aa55fe1a712016-05-16

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
15187-03615187-036-04, 15187-036-08

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
AMMONIUM GLYCYRRHIZATE3VRD35U26CIACT
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16IACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
METHYLPARABENA2I8C7HI9TIACT
POTASSIUM BENZOATE763YQN2K7KIACT
PROPYLPARABENZ8IX2SC1OHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
CHLORPHENIRAMINE MALEATEV1Q0O9OJ9ZACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
fc10a9ab-b0a8-288f-e053-6394a90a10825bbbb3f0-40bc-4dee-b352-a834a4a099082023-05-19WarningsExact identifier
spl id: fc10a9ab-b0a8-288f-e053-6394a90a1082
spl set id: 5bbbb3f0-40bc-4dee-b352-a834a4a09908

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.