FDA.reportPublic FDA data

Scot-Tussin Senior Maximum Strength Cough Suppressant and Expectorant

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 21:31:09

Label at a glance#

ProductScot-Tussin Senior Maximum Strength Cough Suppressant and Expectorant
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure11 sections

Indications and 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.

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Fact

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

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr. USP 15 mg

Purpose

OTC - PURPOSE SECTION

Cough Suppressant

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

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin USP 200mg

Purpose

OTC - PURPOSE SECTION

Expectorant

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

*Phenylketoneurics: Contains Phenylalanine.

Do not use:

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • 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 

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

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.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)

PRINCIPAL DISPLAY PANEL SUGAR-FREE ADULT NDC 15187-050-04 For Diabetics since 1956 SCOT-TUSSIN® SENIOR MAXIMUM STRENGTH COUGH SUPPRESSANT & EXPECTORANT DEXTROMETHORPHAN HBr (Cou...PRINCIPAL DISPLAY PANEL SUGAR-FREE ADULT NDC 15187-050-04 For Diabetics since 1956 SCOT-TUSSIN® SENIOR MAXIMUM STRENGTH COUGH SUPPRESSANT & EXPECTORANT DEXTROMETHORPHAN HBr (Cou...

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
15187-050-04ML - Milliliter15187-05068bcd496-8fc7-459e-8e9f-e3af1797df1a12016-05-16

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
15187-05015187-050-04, 15187-050-08

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
ASPARTAMEZ0H242BBR1IACT
BENZOIC ACID8SKN0B0MIMIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
HYPROMELLOSES3NXW29V3WOIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB

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
fc10f11a-0892-9fe4-e053-6394a90ab09c87b84231-9269-48fd-9f3b-9db0e9c216542023-05-19WarningsExact identifier
spl id: fc10f11a-0892-9fe4-e053-6394a90ab09c
spl set id: 87b84231-9269-48fd-9f3b-9db0e9c21654

Reported adverse events (FAERS/openFDA)#

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