CODEINE PHOSPHATE AND GUAIFENESIN liquid

Codeine Phosphate and Guaifenesin by

Drug Labeling and Warnings

Codeine Phosphate and Guaifenesin by is a Otc medication manufactured, distributed, or labeled by Virtus Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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 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.

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

VIRTUS®
PHARMACEUTICALS

NDC: 69543-276-16

Codeine phosphate and
Guaifenesin oral solution
10 mg/100 mg Per 5 mL

Antitussive
Expectorant

CV

SUGAR FREE

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

Alcohol 3.8%

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

16 fl. oz. (473 mL)

INGREDIENTS AND APPEARANCE

CODEINE PHOSPHATE AND GUAIFENESIN 
codeine phosphate and guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69543-276
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	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69543-276-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/23/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	10/23/2017

Labeler - Virtus Pharmaceuticals LLC (079659493)