VIRTUSSIN AC W/ALC- codeine phosphate and guaifenesin liquid

VIRTUSSIN AC W/ALC by

Drug Labeling and Warnings

VIRTUSSIN AC W/ALC by is a Otc medication manufactured, distributed, or labeled by Virtus Pharmaceuticals LLC, Nexgen Pharma, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

• Active ingredients(in each 5 mL = 1 tsp):

  Purpose

• Codeine phosphate, USP 10 mg:

  Cough suppressant

• Guaifenesin, USP 100 mg:

  Expectorant

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 cough more productive.

Warnings

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

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

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.

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

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

Directions

• ▪ 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

Each tsp (5 mL) contains 4 mg sodium.
Store at controlled room temperature 15° to 30°C (59° to 86° F).
You may report side effects by calling Virtus Pharmaceuticals, LLC at 1-888-848-3593 or FDA at 1-800-FDA-1088

Inactive ingredients

Alcohol, caramel flavor, cherry flavor, citric acid, FD&C Red #40, glycerin, menthol flavor, purified water, sodium benzoate, sodium saccharin, sorbitol.

SPL UNCLASSIFIED SECTION

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

Rev. 07/2019
7300-0016

PRINCIPAL DISPLAY PANEL – 473 mL Bottle Label

NDC: 69543-251-16

Virtussin
AC W/ALC

Cough Suppressant
Expectorant

CV

SUGAR FREE 3.8% (v/v) ALCOHOL

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

INGREDIENTS AND APPEARANCE

VIRTUSSIN AC W/ALC 
codeine phosphate and guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69543-251
Route of Administration	ORAL	DEA Schedule	CV

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)	CODEINE PHOSPHATE	10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SORBITOL (UNII: 506T60A25R)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor	CARAMEL, CHERRY, MENTHOL	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69543-251-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/04/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	11/04/2019

Labeler - Virtus Pharmaceuticals LLC (079659493)

Establishment
Name	Address	ID/FEI	Business Operations
Nexgen Pharma, Inc.		079424083	MANUFACTURE(69543-251)