Guaifenesin and Codeine Phosphate Oral Solution, USP CV100 mg/10 mg per 5 mL

GUAIFENESIN and CODEINE PHOSPHATE by

Drug Labeling and Warnings

GUAIFENESIN and CODEINE PHOSPHATE by is a Otc medication manufactured, distributed, or labeled by QUAGEN PHARMACEUTICALS LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GUAIFENESIN AND CODEINE PHOSPHATE- guaifenesin and codeine phosphate solution 
QUAGEN PHARMACEUTICALS LLC

----------

Guaifenesin and Codeine Phosphate Oral Solution, USP CV
100 mg/10 mg per 5 mL

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 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

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 1-888-344-9603 or FDA at 1-800-FDA-1088.

Inactive ingredients

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

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

Manufactured by:
Quagen Pharmaceuticals LLC
West Caldwell, NJ 07006

MADE IN USA

PRINCIPAL DISPLAY PANEL-4 fl oz (118 mL) Container Label

PRINCIPAL DISPLAY PANEL-8 fl oz (237 mL) Container Label

PRINCIPAL DISPLAY PANEL-16 fl oz (473 mL) Container Label

GUAIFENESIN AND CODEINE PHOSPHATE 
guaifenesin and codeine phosphate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70752-177
Route of Administration	ORAL	DEA Schedule	CIII

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

Inactive Ingredients
Ingredient Name	Strength
DEHYDRATED ALCOHOL (UNII: 3K9958V90M)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70752-177-06	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/23/2022	03/22/2025
2	NDC: 70752-177-15	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/23/2022	03/22/2025
3	NDC: 70752-177-12	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/23/2022	03/22/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	05/23/2022	03/22/2025

Labeler - QUAGEN PHARMACEUTICALS LLC (073645339)

Registrant - QUAGEN PHARMACEUTICALS LLC (073645339)

Establishment
Name	Address	ID/FEI	Business Operations
QUAGEN PHARMACEUTICALS LLC		080281331	manufacture(70752-177) , pack(70752-177)

Revised: 6/2025

Document Id: ff8c0520-2b01-4496-a75e-edc0975b4849

34390-5

Set id: e53bf6a7-5d11-4372-93dd-2a2e9acdbda0

Version: 5

Effective Time: 20250624