FDA.reportPublic FDA data

Scot-Tussin Original Multi-Symptom Cold and Allergy Relief

Manufacturer
IriSys, LLC
Effective date
2015-10-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:44:33

Label at a glance#

ProductScot-Tussin Original Multi-Symptom Cold and Allergy Relief
Active ingredientACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, PHENIRAMINE MALEATE
Label structure12 sections

Indications and uses

temporarily relieves these symptoms due to a cold: minor aches and pains. headaches. minor sore throat. nasal congestion. temporarily reduces fever. temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose. sneezing. itchy nose and throat. itchy, watery eyes.

Dosage and administration

do not use more than directed – see Liver warning. 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 each teaspoon (5 mL) contains: Potassium 17.5 mg. store at 20°- 25° C (68°-77°F). do ...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL tsp. teaspoon)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen USP 160 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/Fever reducer

Active ingredient (in each 5 mL tsp. teaspoon)

OTC - ACTIVE INGREDIENT SECTION

Pheniramine Maleate USP 4 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Active ingredient (in each 5 mL tsp. teaspoon)

OTC - ACTIVE INGREDIENT SECTION

Phenylephrine HCI USP 4 mg

Purpose

OTC - PURPOSE SECTION

Decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these symptoms due to a cold:
    • minor aches and pains.
    • headaches.
    • minor sore throat.
    • nasal congestion.
    • temporarily reduces fever.

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose.
    • sneezing.
    • itchy nose and throat.
    • itchy, watery eyes.

Warnings

WARNINGS SECTION

DO NOT USE THIS PRODUCT TO SEDATE CHILDREN

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 4 doses in 24 hours, which is the maximum daily amount.
  • with other drugs containing acetaminophen.
  • 3 or more alcoholic drinks every day while using this product.

Do not use:

OTC - DO NOT USE SECTION

  • with any other drug containing acetaminophen (prescription or nonprescription).
    if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • 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

  • liver disease.
  • heart disease.
  • high blood pressure.
  • thyroid disease.
  • diabetes.
  • glaucoma.
  • a breathing problem such as emphysema, asthma or chronic bronchitis.
  • trouble urinating due to an enlarged prostate gland.

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking sedatives or tranquilizers.
  • taking the blood thinning drug warfarin.

When using this product

OTC - WHEN USING SECTION

  • do not use more than directed.
  • avoid alcoholic drinks.
  • drowsiness may occur.
  • alcohol, sedatives and tranquilizers may increase drowsiness.
  • be careful when driving a motor vehicle or operating machinery.
  • excitability may occur, especially in children.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you get nervous, dizzy or sleepless.
  • pain or nasal congestion gets worse or lasts more than 7 days.
  • fever gets worse or lasts more than 3 days.
  • redness or swelling is present.
  • new symptoms occur.
  • sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting.

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 overdose get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not use more than directed – see Liver warning.
  • 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 (5 mL) contains: Potassium 17.5 mg.
  • store at 20°- 25° C (68°-77°F).
  • do not refrigerate.
  • dosage cup provided

Inactive ingredients

INACTIVE INGREDIENT SECTION

ammonium glycyrrhizate, citric acid, clear cherry-strawberry flavor, glycerin, hydroxyethylcelluose, methyl-paraben, polyethylene glycol, potassium benzoate, potassium citrate, propyl-paraben, purified water, sucralose.

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 15187-004-04
For Diabetics since 1956
SCOT-TUSSIN®
ORIGINAL
MULTI-SYMPTOM
COLD & ALLERGY RELIEF
ACETAMINOPHEN (pain reliever, fever reducer)
PHENIRAMINE MALEATE (antihistamine)
PHENYLEPHRINE HCI (nasal decongestant)

FAST RELIEF OF:
PAIN, FEVER, STUFFY HEAD,
SINUS CONGESTION, ITCHY,
RUNNY NOSE

  • FIRST SUGAR & ALCOHOL-FREE
  • LACTOSE & GLUTEN-FREE
  • SODIUM-FREE
  • DYE-FREE

LIQUID
4 FL OZ (118 ml)

PRINCIPAL DISPLAY PANEL SUGAR-FREE ADULT NDC 15187-004-04 For Diabetics since 1956 SCOT-TUSSIN® ORIGINAL MULTI-SYMPTOM COLD & ALLERGY RELIEF ACETAMINOPHEN (pain reliever, fever ...PRINCIPAL DISPLAY PANEL SUGAR-FREE ADULT NDC 15187-004-04 For Diabetics since 1956 SCOT-TUSSIN® ORIGINAL MULTI-SYMPTOM COLD & ALLERGY RELIEF ACETAMINOPHEN (pain reliever, fever ...

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1367384acetaminophen 160 MG / pheniramine maleate 4 MG / phenylephrine HCl 4 MG in 5 mL Oral SolutionPSN2
1367384acetaminophen 32 MG/ML / pheniramine maleate 0.8 MG/ML / phenylephrine hydrochloride 0.8 MG/ML Oral SolutionSCD2
1367384acetaminophen 160 MG / pheniramine maleate 4 MG / phenylephrine HCl 4 MG per 5 ML Oral SolutionSY2
1367384APAP 32 MG/ML / Pheniramine Maleate 0.8 MG/ML / Phenylephrine Hydrochloride 0.8 MG/ML Oral SolutionSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
15187-004-042020-01-31C16284748780-19d75b9d0-a72f-f424-e053-dadaa90a57ceScot-Tussin Original Multi-Symptom Cold and Allergy Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
15187-004-04Scot-Tussin Original Multi-Symptom Cold and Allergy Relief118 mL in 1 BOTTLELIQUID1182
15187-004-04Scot-Tussin Original Multi-Symptom Cold and Allergy Relief1 in 1 CARTONLIQUID12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15187-004SCOT-TUSSIN ORIGINAL MULTI-SYMPTOM COLD AND ALLERGY RELIEF (ACETOMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) LIQUID [IRISYS, LLC]2Legacy NDC, 2 package rows20160101_ce11862b-24c6-4d51-87a9-930858a47de5.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
15187-00415187-004-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
PHENIRAMINE MALEATENYW905655BACTIB
AMMONIUM GLYCYRRHIZATE3VRD35U26CIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16IACT
METHYLPARABENA2I8C7HI9TIACT
POLYETHYLENE GLYCOLS3WJQ0SDW1AIACT
POTASSIUM BENZOATE763YQN2K7KIACT
POTASSIUM CITRATEEE90ONI6FFIACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SUCRALOSE96K6UQ3ZD4IACT

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
493ea01e-aa58-4f68-909e-031defb2338ece11862b-24c6-4d51-87a9-930858a47de52015-10-15WarningsExact identifier
spl id: 493ea01e-aa58-4f68-909e-031defb2338e
spl set id: ce11862b-24c6-4d51-87a9-930858a47de5

Reported adverse events (FAERS/openFDA)#

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