Virtussin AC

Manufacturer: Virtus Pharmaceuticals
Effective date: 2022-08-17
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: legacy-cache
Hydrated at: 2026-08-01 21:53:17

Label at a glance#

ProductVirtussin AC

Active ingredientCodeine phosphate, Guaifenesin

Label structure8 sections

Indications and uses

▪ temporarily relieves: ▪ cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants ▪ your cough to help you sleep ▪ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Dosage and administration

▪ do not exceed 6 doses in 24 hours. 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.

Storage and handling

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

Uses

INDICATIONS & USAGE SECTION

temporarily relieves:
cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants
your cough to help you sleep
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Warnings

WARNINGS SECTION

OTC - ASK DOCTOR SECTION

Ask your doctor before use if

you have a persistent cough, this may be a sign of a serious condition
you have a persistent cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
you have a cough that is accompanied by excessive phlegm (mucus)
you have chronic pulmonary disease or shortness of breath
giving to a child who is taking other drugs

OTC - WHEN USING SECTION

When using this product

giving a higher dose than recommended by a doctor could result in serious side effects for your child. A special measuring device should be used to give an accurate dose of this product to children under 6 years of age.
may cause or aggravate constipation

OTC - STOP USE SECTION

Stop use and ask a doctor if

symptoms do not improve within 7 days, tend to recur or are accompanied by fever and rash or persistent headache. These may be symptoms 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 6 doses in 24 hours.

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

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

Cherry flavor, citric acid, methylparaben, potassium citrate, potassium sorbate, propylparaben, propylene glycol, purified water, sorbitol, sucralose.

Manufactured for: Virtus Pharmaceuticals, LLC
Langhorne, PA 19047
1-888-848-3593
Made in USA

Rev. 07/2019
7270-0016

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 69543-252-16

Virtussin
AC

Cough Suppressant
Expectorant

SUGAR FREE • DYE FREE
ALCOHOL FREE

Each 5 mL (1 teaspoonful) contains:
Codeine phosphate, USP . . . 10 mg
Guaifenesin, USP . . . . . . . 100 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)

VIRTUS^®
PHARMACEUTICALS

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69543-252-04	ML - Milliliter	69543-252	b8536b74-70ed-422d-9092-ea1739b225ff	1	2015-10-02
69543-252-16	ML - Milliliter	69543-252	11a1b225-86f3-4aa3-847b-f7c5f169acef	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
Codeine anhydrous	ACTIVE MOIETY	UX6OWY2V7J	1
Guaifenesin	ACTIVE MOIETY	495W7451VQ	1
citric acid monohydrate	INACTIVE INGREDIENT	2968PHW8QP	1
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	1
potassium citrate	INACTIVE INGREDIENT	EE90ONI6FF	1
potassium sorbate	INACTIVE INGREDIENT	1VPU26JZZ4	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	1
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	1
sorbitol	INACTIVE INGREDIENT	506T60A25R	1
sucralose	INACTIVE INGREDIENT	96K6UQ3ZD4	1
water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

Virtussin AC
Codeine phosphate and Guaifenesin
Codeine phosphate
Codeine anhydrous
Guaifenesin
citric acid monohydrate
methylparaben
potassium citrate
potassium sorbate
propylparaben
propylene glycol
water
sorbitol
sucralose

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69543-252	69543-252-04, 69543-252-16

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
Codeine phosphate	GSL05Y1MN6	ACTIB
Guaifenesin	495W7451VQ	ACTIB
citric acid monohydrate	2968PHW8QP	IACT
methylparaben	A2I8C7HI9T	IACT
potassium citrate	EE90ONI6FF	IACT
potassium sorbate	1VPU26JZZ4	IACT
propylparaben	Z8IX2SC1OH	IACT
propylene glycol	6DC9Q167V3	IACT
water	059QF0KO0R	IACT
sorbitol	506T60A25R	IACT
sucralose	96K6UQ3ZD4	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 7 · 405 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
methylparaben	METHYLPARABEN	A2I8C7HI9T	EMULSION / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRAVENOUS	2068 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
potassium sorbate	POTASSIUM SORBATE	1VPU26JZZ4	EMULSION / OPHTHALMIC	0.47 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / INTRAOCULAR		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	OINTMENT / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	EMULSION / TOPICAL	7 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	CREAM / TOPICAL		3000 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	TABLET, EFFERVESCENT / ORAL		1080 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	TABLET / ORAL		45 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	GUM, CHEWING / BUCCAL		5110 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	SUSPENSION, EXTENDED RELEASE / ORAL		16 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION/ DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / TOPICAL		17 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SHAMPOO / TOPICAL	0.03 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	CAPSULE / ORAL		1111 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
potassium sorbate	POTASSIUM SORBATE	1VPU26JZZ4	TABLET, EXTENDED RELEASE / ORAL	0.2 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, COATED / ORAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	TABLET, CHEWABLE / ORAL	0.14 mg		Exact identifier — unii candidate 68 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
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	FILM / BUCCAL	0.22 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	PASTE / DENTAL	14.6 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	JELLY / TOPICAL	20 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	DROPS / ORAL	NA		Exact identifier — unii candidate 88 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	FILM, SOLUBLE / BUCCAL		5 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / INTRAMUSCULAR	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / TOPICAL	0.24 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION/ DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SYSTEM / TOPICAL	0.2 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	EMULSION / TOPICAL	0.06 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / ORAL		388 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	SOLUTION / ORAL		800 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
potassium sorbate	POTASSIUM SORBATE	1VPU26JZZ4	CREAM / TOPICAL	0.25 %w/w		Exact identifier — unii candidate 19 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / RECTAL		90400 mg	Exact identifier — unii candidate 81 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	FILM / BUCCAL	1.48 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	TABLET / ORAL	337.28 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / SOFT TISSUE	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	CONCENTRATE / ORAL		12 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / RECTAL	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	SUSPENSION / RECTAL	46.18 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / ORAL		64 mg	Exact identifier — unii candidate 68 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
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / SUBCUTANEOUS		28 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / SUBCUTANEOUS	1.4 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	OINTMENT / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / PARENTERAL		30 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / PERINEURAL		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	CAPSULE, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SHAMPOO, SUSPENSION / TOPICAL	0.15 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	TABLET, EXTENDED RELEASE / ORAL	0.17 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	PASTE, DENTIFRICE / DENTAL	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	GEL / TOPICAL		4 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE / ORAL		1072 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	LIQUID / ORAL		53460 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUPPOSITORY / VAGINAL	252 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SOLUTION / INTRAMUSCULAR		5 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SPRAY / TOPICAL	0.2 %w/w		Exact 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
53905911-2305-4d4e-ab1a-9aa168361123			718f699a-c5eb-4e2b-b43e-45525ecf6502	2022-08-17	Warnings	Exact identifier spl id: 53905911-2305-4d4e-ab1a-9aa168361123 spl set id: 718f699a-c5eb-4e2b-b43e-45525ecf6502

Reported adverse events (FAERS/openFDA)#

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