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

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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

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

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

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GUAIFENESIN AND CODEINE PHOSPHATE 
guaifenesin and codeine phosphate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70752-177
Route of AdministrationORALDEA ScheduleCIII    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) CODEINE PHOSPHATE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorCARAMEL, CHERRY, PEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70752-177-06118 mL in 1 BOTTLE; Type 0: Not a Combination Product05/23/202203/22/2025
2NDC:70752-177-15237 mL in 1 BOTTLE; Type 0: Not a Combination Product05/23/202203/22/2025
3NDC:70752-177-12473 mL in 1 BOTTLE; Type 0: Not a Combination Product05/23/202203/22/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01205/23/202203/22/2025
Labeler - QUAGEN PHARMACEUTICALS LLC (073645339)
Registrant - QUAGEN PHARMACEUTICALS LLC (073645339)
Establishment
NameAddressID/FEIBusiness Operations
QUAGEN PHARMACEUTICALS LLC080281331manufacture(70752-177) , pack(70752-177)

Revised: 6/2025
Document Id: ff8c0520-2b01-4496-a75e-edc0975b4849
Set id: e53bf6a7-5d11-4372-93dd-2a2e9acdbda0
Version: 5
Effective Time: 20250624
 
QUAGEN PHARMACEUTICALS LLC