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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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

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

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

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 ScheduleCV    
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 Product05/23/2022
2NDC:70752-177-15237 mL in 1 BOTTLE; Type 0: Not a Combination Product05/23/2022
3NDC:70752-177-12473 mL in 1 BOTTLE; Type 0: Not a Combination Product05/23/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/23/2022
Labeler - QUAGEN PHARMACEUTICALS LLC (073645339)
Registrant - QUAGEN PHARMACEUTICALS LLC (073645339)
Establishment
NameAddressID/FEIBusiness Operations
QUAGEN PHARMACEUTICALS LLC080281331manufacture(70752-177) , pack(70752-177)

Revised: 7/2022
Document Id: 13fcb9d6-8f2d-4cce-9a61-a87de3d92419
Set id: e53bf6a7-5d11-4372-93dd-2a2e9acdbda0
Version: 2
Effective Time: 20220703
 
QUAGEN PHARMACEUTICALS LLC