CODEINE-GUAIFENESIN- codeine phosphate and guaifenesin solution 
Method 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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Codeine-Guaifenesin Oral Solution

Active ingredient

(in each teaspoonful (5 mL))
Codeine Phosphate USP 10 mg

Purpose

Antitussive

Active ingredient

(in each teaspoonful (5 mL))
Guaifenesin USP 100 mg

Purpose

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

  • 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 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

Store at controlled room temperature 15°-30°C (59°-86°F).

Inactive ingredients

Cherry Flavor, Citric Acid, Glycerin,Masking flavor, Propylene glycol, Purified Water, Sodium Citrate, Sodium Benzoate, Sucralose Sorbitol.

Principal Display Panel

NDC 58657-500-16

Codeine-Guaifenesin Oral Solution

10-100 mg/5 mL

Antitussive

Expectorant

16 fl. oz. (473 mL)

label

CODEINE-GUAIFENESIN 
codeine phosphate and guaifenesin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58657-500
Route of AdministrationORALDEA ScheduleCV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) CODEINE PHOSPHATE10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SORBITOL (UNII: 506T60A25R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58657-500-04120 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2014
2NDC:58657-500-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/01/2014
Labeler - Method Pharmaceuticals, LLC (060216698)

Revised: 11/2022
Document Id: ed9f20f9-2043-4bfd-e053-2995a90a5429
Set id: fe126254-6ee6-48c3-965c-96e4276a5314
Version: 12
Effective Time: 20221116
 
Method Pharmaceuticals, LLC