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NDC 71205-0363-04 Virtussin A/C 10; 100 mg/5mL; mg/5mL Details

Virtussin A/C 10; 100 mg/5mL; mg/5mL

Virtussin A/C is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Proficient Rx LP. The primary component is CODEINE PHOSPHATE; GUAIFENESIN.

MedlinePlus Drug Summary

Codeine is used to relieve mild to moderate pain. It is also used, usually in combination with other medications, to reduce coughing. Codeine will help relieve symptoms but will not treat the cause of symptoms or speed recovery. Codeine belongs to a class of medications called opiate (narcotic) analgesics and to a class of medications called antitussives. When codeine is used to treat pain, it works by changing the way the brain and nervous system respond to pain. When codeine is used to reduce coughing, it works by decreasing the activity in the part of the brain that causes coughing. Codeine is also available in combination with acetaminophen (Capital and Codeine, Tylenol with Codeine), aspirin, carisoprodol, and promethazine and as an ingredient in many cough and cold medications. This monograph only includes information about the use of codeine. If you are taking a codeine combination product, be sure to read information about all the ingredients in the product you are taking and ask your doctor or pharmacist for more information.

Related Packages: 71205-0363-04
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Codeine

Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.

Related Packages: 71205-0363-04
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin

Product Information

NDC	71205-0363
Product ID	71205-363_d9a7c7eb-22e1-4361-a708-99f4ed5c3a2c
Associated GPIs	43997002282020
GCN Sequence Number	045669
GCN Sequence Number Description	codeine phosphate/guaifenesin LIQUID 10-100MG/5 ORAL
HIC3	B4S
HIC3 Description	OPIOID ANTITUSSIVE-EXPECTORANT COMBINATION
GCN	91713
HICL Sequence Number	000206
HICL Sequence Number Description	CODEINE PHOSPHATE/GUAIFENESIN
Brand/Generic	Generic
Proprietary Name	Virtussin A/C
Proprietary Name Suffix	n/a
Non-Proprietary Name	Codeine phosphate and Guaifenesin
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	10; 100
Active Ingredient Units	mg/5mL; mg/5mL
Substance Name	CODEINE PHOSPHATE; GUAIFENESIN
Labeler Name	Proficient Rx LP
Pharmaceutical Class	Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA Schedule	CV
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2024-12-31

Package

Package Images

NDC 71205-0363-04 (71205036304)

Pricing Information	N/A
NDC Package Code	71205-363-04
Billing NDC	71205036304
Package	118 mL in 1 BOTTLE (71205-363-04)
Marketing Start Date	2019-11-21
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d9a7c7eb-22e1-4361-a708-99f4ed5c3a2c Details

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients (in each 5 mL = 1 tsp)	Purpose
Codeine phosphate, USP 10 mg	Antitussive
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 coughs 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

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

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

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC: 71205-363-04

Virtussin

A/C

Antitussive

Expectorant

ALCOHOL-FREE / SUGAR-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)

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

INGREDIENTS AND APPEARANCE

VIRTUSSIN A/C

codeine phosphate and guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71205-363(NDC:69543-252)
Route of Administration	ORAL	DEA Schedule	CV

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
citric acid monohydrate (UNII: 2968PHW8QP)
methylparaben (UNII: A2I8C7HI9T)
potassium citrate (UNII: EE90ONI6FF)
potassium sorbate (UNII: 1VPU26JZZ4)
propylparaben (UNII: Z8IX2SC1OH)
propylene glycol (UNII: 6DC9Q167V3)
water (UNII: 059QF0KO0R)
sorbitol (UNII: 506T60A25R)
sucralose (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71205-363-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/21/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	07/07/2015

Labeler - Proficient Rx LP (079196022)

Name	Address	ID/FEI	Business Operations
Establishment
Proficient Rx LP		079196022	REPACK(71205-363) , RELABEL(71205-363)

Revised: 11/2019

Document Id: d9a7c7eb-22e1-4361-a708-99f4ed5c3a2c

Set id: d9a7c7eb-22e1-4361-a708-99f4ed5c3a2c

Version: 1

Effective Time: 20191101

Search by Drug Name or NDC

NDC 71205-0363-04 Virtussin A/C 10; 100 mg/5mL; mg/5mL Details

Virtussin A/C 10; 100 mg/5mL; mg/5mL

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 71205-0363-04 (71205036304)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL d9a7c7eb-22e1-4361-a708-99f4ed5c3a2c Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Uses

Warnings

Directions

Other information

Inactive ingredients

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

INGREDIENTS AND APPEARANCE

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