FDA.reportPublic FDA data

Scot-Tussin Original SF Multi-Symptom

Manufacturer
SCOT-TUSSIN Pharmacal Co., Inc.
Effective date
2013-01-25
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 22:34:18

Label at a glance#

ProductScot-Tussin Original SF Multi-Symptom
Active ingredientACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, PHENIRAMINE MALEATE
Label structure12 sections

Indications and uses

temporarily relieves these symptoms due to a cold: minor aches and pains. minor sore throat. temporarily reduces fever. headaches. nasal congestion. temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose. itchy nose and throat. sneezing. 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. 10ml.) every 6 hours Children under 12 years old DO NOT USE

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each 5 mL. tsp. teaspoon)
Acetaminophen USP 160 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/Fever reducer

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each 5 mL. tsp. teaspoon)
Pheniramine Maleate USP 4 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each 5 mL. tsp. teaspoon)
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.
    • minor sore throat.
    • temporarily reduces fever.
    • headaches.
    • nasal congestion.

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

Warnings

WARNINGS SECTION

DO NOT USE THIS PRODUCT TO SEDATE CHILDREN

Liver warning: This product contains acetaminophne. Severe liver damange 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 monoamie 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 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 broncititis.
  • trouble uritinating 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 old		2 teaspoons
(2 tsp. 10ml.)
every 6 hours
Children under
12 years old		DO NOT USE

Other Information

SPL UNCLASSIFIED SECTION

  • each teaspoon (5 ml.) contains:
    Potassium 17.5 mg.
  • Store at 20º – 25º C (68º – 77º F).
  • do not refrigerate.
  • dosage cup provided.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SCOT-
TUSSIN
MULTI-SYMPTOM
COLD & ALLERGY

SCOT- TUSSIN MULTI-SYMPTOM COLD & ALLERGYSCOT- TUSSIN MULTI-SYMPTOM COLD & ALLERGY

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 SolutionPSN6
1367384acetaminophen 32 MG/ML / pheniramine maleate 0.8 MG/ML / phenylephrine hydrochloride 0.8 MG/ML Oral SolutionSCD6
1367384acetaminophen 160 MG / pheniramine maleate 4 MG / phenylephrine HCl 4 MG per 5 ML Oral SolutionSY6
1367384APAP 32 MG/ML / Pheniramine Maleate 0.8 MG/ML / Phenylephrine Hydrochloride 0.8 MG/ML Oral SolutionSY6

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
0372-0004-042020-01-31C16284748780-19d75b9d1-178b-f424-e053-dadaa90a57ceScot-Tussin Original SF Multi-Symptom

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0372-0004-04Scot-Tussin Original SF Multi-Symptom118 mL in 1 BOTTLELIQUID1186

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0372-0004SCOT-TUSSIN ORIGINAL SF MULTI-SYMPTOM (ACETOMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) LIQUID [SCOT-TUSSIN PHARMACAL CO., INC.]6Legacy NDC, 1 package rows20130124_f142eec2-1764-4086-b24e-fbff358ed8df.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9D6
PHENIRAMINE MALEATEACTIVE INGREDIENTNYW905655B6
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJ6
ACETAMINOPHENACTIVE MOIETY362O9ITL9D6
PHENIRAMINEACTIVE MOIETY134FM9ZZ6M6
PHENYLEPHRINEACTIVE MOIETY1WS297W6MV6
AMMONIUM GLYCYRRHIZATEINACTIVE INGREDIENT3VRD35U26C6
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP6
GLYCERININACTIVE INGREDIENTPDC6A3C0OX6
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)INACTIVE INGREDIENTS38J6RZN166
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T6
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1A6
POTASSIUM BENZOATEINACTIVE INGREDIENT763YQN2K7K6
POTASSIUM CITRATEINACTIVE INGREDIENTEE90ONI6FF6
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH6
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD46
WATERINACTIVE INGREDIENT059QF0KO0R6

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
0372-00040372-0004-04

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
SUCRALOSE96K6UQ3ZD4IACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 351 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
METHYLPARABENMETHYLPARABENA2I8C7HI9TPOWDER, FOR SOLUTION / ORAL126 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHPASTE, DENTIFRICE / DENTALNAExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
68 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLIQUID / RESPIRATORY (INHALATION)0.13 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR0.4 mgExact identifier — unii candidate
68 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4POWDER, FOR SOLUTION / ORAL414 mgExact identifier — unii candidate
22 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSYSTEM / IONTOPHORESIS0.2 mgExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXEMULSION / INTRAVENOUS2.2 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS608 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRA-ARTICULARADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / TOPICAL216 mgExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / OPHTHALMIC58 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, EMULSION / INTRAVENOUS24100 mgExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPPOWDER, FOR SUSPENSION / ORAL840 mgExact identifier — unii candidate
88 equally ranked IID candidates
POTASSIUM CITRATEPOTASSIUM CITRATEEE90ONI6FFAEROSOL, FOAM / TOPICAL12 mgExact identifier — unii candidate
4 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRAVENOUS2068 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPAEROSOL, FOAM / RECTAL7 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPDROPS / ORALNAExact identifier — unii candidate
88 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION, SOLUTION / INTRAMUSCULAR5 mgExact identifier — unii candidate
68 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPELIXIR / ORAL100 mg/5mlExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE, DENTIFRICE / DENTAL18 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SPRAY / NASAL2 mgExact identifier — unii candidate
22 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHFILM, SOLUBLE / BUCCAL1 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION / INTRA-ARTICULAR0.03 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / TOPICAL17 mgExact identifier — unii candidate
88 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION, SOLUTION / INTRAMUSCULAR45 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TDROPS / NASAL26 mgExact identifier — unii candidate
79 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION, CONCENTRATE / INTRAOCULAR1 mgExact identifier — unii candidate
88 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION, EXTENDED RELEASE / ORAL40 mgExact identifier — unii candidate
79 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
22 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16TABLET, EXTENDED RELEASE / ORAL350 mgExact identifier — unii candidate
15 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHTABLET, EXTENDED RELEASE / ORAL0.12 mgExact identifier — unii candidate
68 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRALESIONALADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / NASAL10 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TROCHE / ORAL60 mgExact identifier — unii candidate
22 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSPRAY / NASAL9 mgExact identifier — unii candidate
88 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TENEMA / RECTAL0.18 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLIQUID / ORAL114 mgExact identifier — unii candidate
88 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUPPOSITORY / VAGINALNAExact identifier — unii candidate
79 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS385 mgExact identifier — unii candidate
88 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TTABLET, EXTENDED RELEASE / ORAL0.17 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / INFILTRATION80 mgExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / ORAL3822 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / RECTAL440 mgExact identifier — unii candidate
75 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SUSPENSION, EXTENDED RELEASE / ORAL16 mgExact identifier — unii candidate
22 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION / ORAL64 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCREAM / VAGINAL3 mgExact identifier — unii candidate
68 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SUSPENSION / ORAL100 mgExact identifier — unii candidate
15 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TAEROSOL, FOAM / VAGINAL0.1 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION / INTRALESIONAL0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / INTRAMUSCULAR0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHTABLET, COATED / ORAL0.8 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR3.6 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHELIXIR / ORAL200 mgExact identifier — unii candidate
68 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / INTRALESIONAL0.15 %w/vExact identifier — unii candidate
79 equally ranked IID candidates

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
c863b9be-68be-404d-8a21-16237bbcf43ef142eec2-1764-4086-b24e-fbff358ed8df2013-01-25WarningsExact identifier
spl id: c863b9be-68be-404d-8a21-16237bbcf43e
spl set id: f142eec2-1764-4086-b24e-fbff358ed8df

Reported adverse events (FAERS/openFDA)#

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