Tusicof

Manufacturer: Kramer Novis.
Effective date: 2018-12-15
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 22:57:58

Label at a glance#

ProductTusicof

Active ingredientGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE

Label structure9 sections

Indications and uses

helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes temporarily relieves these symptoms occurring with a cold: nasal congestions cough due to minor throat and bronchial irritation

Dosage and administration

Adults and children 12 years of age or older: Take 1 caplet every 4 hours as needed, do not exceed 6 caplets in 24 hours, or as directed by a doctor. Children under 12 years: consult a doctor.

Storage and handling

Tamper evident feature: Do not use if packet is torn, cut or open. Store at controlled room temperature 15-30°C (59-86°F). Avoid excessive heat and humidity.

Contacts and useful links#

PhoneLabel contact(787) 767-2072

Websitewww.kramernovis.com

www.kramernovis.com

Label contents#

Full prescribing information#

Active Ingredients (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr, 20 mg

Guaifenesin, 400 mg

Phenylephrine HCl, 10 mg

Purpose

OTC - PURPOSE SECTION

Cough suppressant

Expectorant

Nasal Decongestant

Uses

INDICATIONS & USAGE SECTION

helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
temporarily relieves these symptoms occurring with a cold:
- nasal congestions
- cough due to minor throat and bronchial irritation

Warnings

WARNINGS SECTION

Do not use 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
• diabetes • heart disease • thyroid disease • high blood pressure
• trouble urinating due to an enlarged prostate gland
• cough that occurs with too much phlegm (mucus)
• cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

When using this product do not exceed recommended dose.

Stop use and ask a doctor if
• symptoms do not improve • new symptoms occur
• redness or swelling is present
• nervousness, dizziness or sleeplessness occur
• symptoms do not improve within 7 days or are accompanied by fever
• cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash or a persistent headache. A persistent cough may be a sign of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age or older: Take 1 caplet every 4 hours as needed, do not exceed 6 caplets in 24 hours, or as directed by a doctor.

Children under 12 years: consult a doctor.

Other Information

STORAGE AND HANDLING SECTION

Tamper evident feature: Do not use if packet is torn, cut or open.
Store at controlled room temperature 15-30°C (59-86°F).
Avoid excessive heat and humidity.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, sodium starch glycolate, stearic acid

SPL UNCLASSIFIED SECTION

Dextromethorphan HBr

COUGH SUPPRESSANT

Guaifenesin

EXPECTORANT

Phenylphrine HCL

NASAL DECONGESTANT

SUGAR & DYE FREE

Manufactured in the USA for Kramer Novis

San Juan, PR 00917. Tel: (787) 767-2072

www.kramernovis.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tusicofnw

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1305214	Dextromethorphan/guaiFENesin/Phenylephrine (Oral Pill)	dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG Oral Tablet	SCD Active

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1305214	dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG Oral Tablet	PSN	3
1305214	dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG Oral Tablet	SCD	3
1305214	dextromethorphan hydrobromide 20 MG / GG 400 MG / phenylephrine hydrochloride 10 MG Oral Tablet	SY	3

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DEXTROMETHORPHAN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813
GUAIFENESIN Pharmacologic Class Indexing	1	Indexing - Pharmacologic Class	20211129
PHENYLEPHRINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52083-289-02	2023-01-30	C162847	48780-1	f386c649-9cd7-0266-e053-dadaa90a7c1a	TUSICOF ®
52083-289-60	2023-01-30	C162847	48780-1	f386c649-9cd7-0266-e053-dadaa90a7c1a	TUSICOF ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52083-289-02	Tusicof	2 in 1 PACKET	TABLET, COATED	2		3
52083-289-60	Tusicof	60 in 1 BOTTLE	TABLET, COATED	60		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52083-289	TUSICOF (GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN) TABLET, COATED [KRAMER NOVIS.]	3	Legacy NDC, 2 package rows	20181227_e6391d61-36ea-4926-878c-6758f65caa7e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52083-289-60	EA - Each	52083-289	e5a033aa-06a7-4cf1-af79-d4558ea726d1	1	2013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	1
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	1
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	1
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	1
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	1
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	1
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	1
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	1

Products#

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

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

Tusicof
Guaifenesin, phenylephrine HCL, Dextromethorphan
GUAIFENESIN
DEXTROMETHORPHAN HYDROBROMIDE
DEXTROMETHORPHAN
PHENYLEPHRINE HYDROCHLORIDE
PHENYLEPHRINE
HYPROMELLOSE, UNSPECIFIED
MALTODEXTRIN
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE K30
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
52083-289	52083-289-02, 52083-289-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
GUAIFENESIN	495W7451VQ	ACTIB
DEXTROMETHORPHAN HYDROBROMIDE	9D2RTI9KYH	ACTIB
PHENYLEPHRINE HYDROCHLORIDE	04JA59TNSJ	ACTIB
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
MALTODEXTRIN	7CVR7L4A2D	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
POVIDONE K30	U725QWY32X	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
STEARIC ACID	4ELV7Z65AP	IACT

Source Document#

Source XML · Source PDF

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 3 · 178 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
POVIDONE K30	POVIDONE K30	U725QWY32X	INSERT / VAGINAL		147 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	TABLET, FILM COATED / ORAL		245 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / SUBLINGUAL	43.2 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LOTION, AUGMENTED / TOPICAL		2070 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / AURICULAR (OTIC)	56.55 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / AURICULAR (OTIC)	10 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	CAPSULE, EXTENDED RELEASE / ORAL		120 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / DENTAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / ORAL		29008 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / OPHTHALMIC	0.6 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	SHAMPOO / TOPICAL	9.7 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	FILM, EXTENDED RELEASE / TRANSDERMAL	58.13 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL, METERED / TOPICAL		1225 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / SUBCUTANEOUS	1.4 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	EMULSION / ORAL	NA		Exact identifier — unii candidate 26 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	TABLET, DELAYED RELEASE PARTICLES / ORAL		70 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SWAB / TOPICAL	34.6 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, EXTENDED RELEASE / ORAL	9 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CONCENTRATE / ORAL		7000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SYRUP / ORAL		5700 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT, AUGMENTED / TOPICAL		714 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, METERED / RECTAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, SOLUTION / INTRAMUSCULAR		4000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / DENTAL	2 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, EXTENDED RELEASE / ORAL		5119 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPONGE / TOPICAL	40 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	DROPS / ORAL	200 mg/1ml		Exact identifier — unii candidate 81 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	GRANULE, DELAYED RELEASE / ORAL	789.6 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, ORALLY DISINTEGRATING / ORAL		1800 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	POWDER, FOR SUSPENSION / ORAL	1203 mg/5ml		Exact identifier — unii candidate 26 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		19 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	TABLET, EXTENDED RELEASE / ORAL		368 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, ORALLY DISINTEGRATING / ORAL		10 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
POLYDEXTROSE	POLYDEXTROSE	VH2XOU12IE	TABLET / ORAL		20 mg	Exact identifier — unii candidate 3 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / RECTAL		3315 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	SOAP / TOPICAL	6 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	EMULSION / OPHTHALMIC	1.5 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	AEROSOL, FOAM / VAGINAL	4 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / TOPICAL		4886 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET / ORAL		64 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY / SUBLINGUAL		36 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, EXTENDED RELEASE / ORAL		200 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 26 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION/ DROPS / OPHTHALMIC	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	FILM / BUCCAL	1.48 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TRANSDERMAL		500 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		12 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CAPSULE / ORAL		90 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CAPSULE, EXTENDED RELEASE / ORAL		64 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / RESPIRATORY (INHALATION)	25 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL		992 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / INTRAMUSCULAR		7459 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	TABLET / SUBLINGUAL		30 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET / BUCCAL	6 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / RECTAL		90400 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	CAPSULE, EXTENDED RELEASE / ORAL		1246 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LOTION / TOPICAL		3392 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		615 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	POWDER, FOR SUSPENSION / ORAL		257 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, DELAYED RELEASE / ORAL		36 mg	Exact identifier — unii candidate 81 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
9f336526-25df-419b-9cc9-b08d7ab5f0f0			e6391d61-36ea-4926-878c-6758f65caa7e	2018-12-15	Warnings	Exact identifier spl id: 9f336526-25df-419b-9cc9-b08d7ab5f0f0 spl set id: e6391d61-36ea-4926-878c-6758f65caa7e

Reported adverse events (FAERS/openFDA)#

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