Virtussin DAC

Manufacturer: Virtus Pharmaceuticals
Effective date: 2019-03-08
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-02 00:29:48

Label at a glance#

ProductVirtussin DAC

Active ingredientCodeine phosphate, Guaifenesin, Pseudoephedrine Hydrochloride

Label structure8 sections

Indications and uses

• temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold • temporarily relieves nasal congestion due to the common cold • temporarily restores freer breathing through the nose • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive • calms the cough control center and relieves coughing

Dosage and administration

• do not exceed 4 doses in any 24 hour period. Attention: A special measuring device should be used to give an accurate dose of this product to children under 6 years of age. Giving a higher dose than recommended by a doctor could result in serious side effects for your child. Adults and children 12 years of age and over: 2 tsp (10 mL) every 4 hours, or as directed by a doctor. Children 6 to under 12 years of age:...

Storage and handling

Each tsp (5 mL) contains 3 mg sodium. Store at controlled room temperature 15°-30°C (59°-86°F). You may report side effects by calling 1-888-848-3593 or FDA at 1-800-FDA-1088.

Contacts and useful links#

PhoneLabel contact1-888-848-3593

PhoneFDA MedWatch1-800-FDA-1088

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

*Active ingredients (in each 5 mL = 1 tsp)*	*Purpose*
Codeine phosphate, USP 10 mg	Cough Suppressant
Guaifenesin, USP 100 mg	Expectorant
Pseudoephedrine HCl, USP 30 mg	Nasal Decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
temporarily relieves nasal congestion due to the common cold
temporarily restores freer breathing through the nose
helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
calms the cough control center and relieves coughing

Warnings

WARNINGS SECTION

OTC - ASK DOCTOR SECTION

Ask your doctor before use if you have

heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to enlarged prostate gland
cough that occurs with excessive phlegm (mucus)
cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Do not use

OTC - DO NOT USE SECTION

in a child under 2 years of age
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.
if you or your child has a chronic pulmonary disease or shortness of breath
if your child is taking other drugs, unless directed by a doctor

When using this product

OTC - WHEN USING SECTION

do not use more than directed
may cause drowsiness
constipation may occur or be aggravated

Stop use and ask a doctor if

OTC - STOP USE SECTION

you get nervous, dizzy, or have trouble sleeping
cough lasts more than 7 days, comes back or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

do not exceed 4 doses in any 24 hour period.

Attention: A special measuring device should be used to give an accurate dose of this product to children under 6 years of age. Giving a higher dose than recommended by a doctor could result in serious side effects for your child.
Adults and children 12 years of age and over:	2 tsp (10 mL) every 4 hours, or as directed by a doctor.
Children 6 to under 12 years of age:	1 tsp (5 mL) every 4 hours, or as directed by a doctor.
Children under 6 years of age:	Consult a doctor.

Other information

STORAGE AND HANDLING SECTION

Each tsp (5 mL) contains 3 mg sodium.

Store at controlled room temperature 15°-30°C (59°-86°F).

You may report side effects by calling 1-888-848-3593 or FDA at 1-800-FDA-1088.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Alcohol, caramel flavor, cherry flavor, citric acid, FD&C red #40, glycerin, menthol flavor, potassium citrate, propylene glycol, purified water, sodium benzoate, sodium saccharin, sorbitol 70% solution.

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VIRTUS
PHARMACEUTICALS

NDC: 69543-253-16

Virtussin
DAC

Cough Suppressant
Expectorant
Nasal Decongestant

SUGAR FREE • 2.1% (v/v) ALCOHOL

Each 5 mL (1 teaspoonful) contains:
Codeine phosphate, USP    10 mg
Guaifenesin, USP    100 mg
Pseudoephedrine HCl, USP    30 mg
(WARNING: May be habit-forming)

Tamper evident by foil
seal under cap.
Do not use if foil seal is
broken or missing.

16 fl. oz. (473 mL)

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69543-253-04	ML - Milliliter	69543-253	48525fd2-8a99-43f8-95e6-f54bff758379	1	2019-02-13
69543-253-16	ML - Milliliter	69543-253	b03fba34-2e05-41b2-b65c-81dc3d9a0513	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Codeine phosphate	ACTIVE INGREDIENT	GSL05Y1MN6	1
Guaifenesin	ACTIVE INGREDIENT	495W7451VQ	1
Pseudoephedrine Hydrochloride	ACTIVE INGREDIENT	6V9V2RYJ8N	1
Codeine Anhydrous	ACTIVE MOIETY	UX6OWY2V7J	1
Guaifenesin	ACTIVE MOIETY	495W7451VQ	1
Pseudoephedrine	ACTIVE MOIETY	7CUC9DDI9F	1
Alcohol	INACTIVE INGREDIENT	3K9958V90M	1
citric acid monohydrate	INACTIVE INGREDIENT	2968PHW8QP	1
FD&C red no. 40	INACTIVE INGREDIENT	WZB9127XOA	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	1
potassium citrate	INACTIVE INGREDIENT	EE90ONI6FF	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	1
saccharin sodium	INACTIVE INGREDIENT	SB8ZUX40TY	1
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	1
sorbitol	INACTIVE INGREDIENT	506T60A25R	1
water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

Virtussin DAC
Codeine phosphate, Guaifenesin, and Pseudoephedrine Hydrochloride
Codeine phosphate
Codeine Anhydrous
Guaifenesin
Pseudoephedrine Hydrochloride
Pseudoephedrine
Alcohol
citric acid monohydrate
FD&C red no. 40
glycerin
potassium citrate
propylene glycol
water
sodium benzoate
saccharin sodium
sorbitol

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69543-253	69543-253-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Codeine phosphate	GSL05Y1MN6	ACTIB
Guaifenesin	495W7451VQ	ACTIB
Pseudoephedrine Hydrochloride	6V9V2RYJ8N	ACTIB
Alcohol	3K9958V90M	IACT
citric acid monohydrate	2968PHW8QP	IACT
FD&C red no. 40	WZB9127XOA	IACT
glycerin	PDC6A3C0OX	IACT
potassium citrate	EE90ONI6FF	IACT
propylene glycol	6DC9Q167V3	IACT
water	059QF0KO0R	IACT
sodium benzoate	OJ245FE5EU	IACT
saccharin sodium	SB8ZUX40TY	IACT
sorbitol	506T60A25R	IACT

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 8 · 448 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
FD&C red no. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, COATED / ORAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	DROPS / ORAL	210 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SPRAY / NASAL	22.3 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
FD&C red no. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE / ORAL		16 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C red no. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, COATED / ORAL	0.1 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	TABLET, FILM COATED / ORAL	5 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SOLUTION / ORAL		6624 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SUSPENSION / ORAL		681 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SYRUP / ORAL		16734 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / ORAL		27120 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	LIQUID / ORAL		3563 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	OINTMENT / TOPICAL		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, COATED / ORAL	25 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SYSTEM / TOPICAL		4200 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	GEL / DENTAL	0.3 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	AEROSOL / TOPICAL		561 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	FILM / BUCCAL	1.48 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / INTRAOCULAR		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	FILM, EXTENDED RELEASE / TRANSDERMAL	306.2 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION / INTRAVENOUS		396 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	CONCENTRATE / ORAL	5.3 mg/1ml		Exact identifier — unii candidate 88 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / NASAL	2.8 mg/1ml		Exact identifier — unii candidate 88 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION/ DROPS / OPHTHALMIC		12 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	MOUTHWASH / BUCCAL	100 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / TOPICAL		1971 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CLOTH / TOPICAL	0.03 mg/mg		Exact identifier — unii candidate 81 equally ranked IID candidates
FD&C red no. 40	FD&C RED NO. 40	WZB9127XOA	POWDER, FOR SOLUTION / ORAL	0.33 mg/5ml		Exact identifier — unii candidate 28 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	GEL / DENTAL	1.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	INJECTION, EMULSION / INTRAVENOUS		520 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	ELIXIR / ORAL		5621 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	GEL / OPHTHALMIC	0.88 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	LOTION / TOPICAL		3990 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	CREAM / VAGINAL		60 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	FILM / SUBLINGUAL		10 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	AEROSOL, FOAM / TOPICAL	4.95 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INFILTRATION	0.02 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	LOTION / TOPICAL	10.7 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	LOTION / TOPICAL	25 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	SOLUTION / OPHTHALMIC		6 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	CAPSULE / ORAL		3487 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	TABLET / PERIODONTAL	0.53 mg		Exact identifier — unii candidate 75 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	SUSPENSION / AURICULAR (OTIC)	10 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	LIQUID / INTRAVENOUS	0.2 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	POWDER, FOR SOLUTION / TOPICAL	40 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	DROPS / NASAL	10 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	GUM, CHEWING / BUCCAL		230 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	GRANULE, FOR SOLUTION / ORAL	5.5 mg/120ml		Exact identifier — unii candidate 34 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / ORAL		446 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SYSTEM / IONTOPHORESIS	0.2 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
FD&C red no. 40	FD&C RED NO. 40	WZB9127XOA	SOLUTION / ORAL		38 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	POWDER, FOR SOLUTION / ORAL		98 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	TABLET / SUBLINGUAL	50.5 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SUSPENSION / ORAL		269 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	GEL / TOPICAL		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SHAMPOO / TOPICAL	8 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
FD&C red no. 40	FD&C RED NO. 40	WZB9127XOA	TABLET / SUBLINGUAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION/ DROPS / OPHTHALMIC	0.75 %w/v		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
e5cd4f21-bc9d-44cd-a327-80af53df7800			1e770927-84c6-4d43-aac8-a64e7c9201ac	2019-03-08	Warnings	Exact identifier spl id: e5cd4f21-bc9d-44cd-a327-80af53df7800 spl set id: 1e770927-84c6-4d43-aac8-a64e7c9201ac

Reported adverse events (FAERS/openFDA)#

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