CODEINE-GUAIFENESIN- codeine phosphate and guaifenesin solution 
Method Pharmaceuticals, Inc.

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.

----------

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

  • 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 makes 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 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

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

Inactive ingredients

Citric Acid, Ethyl Alcohol, FD&C Red #40, Flavoring, Glycerin, Polyethylene Glycol, Povidone, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate, Sodium Saccharin, Sorbitol.

Principal Display Panel

NDC 58657-500-16
Codeine-Guaifenesin Oral Solution
10-100 mg/5 mL
Antitussive
Expectorant
16 fl. oz. (473 mL)

NDC 58657-500-16 Codeine-Guaifenesin Oral Solution 10-100 mg/5 mL Antitussive Expectorant 16 fl. oz. (473 mL)
CODEINE-GUAIFENESIN 
codeine phosphate and guaifenesin solution
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:58657-500
Route of AdministrationORALDEA ScheduleCV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CODEINE PHOSPHATE (CODEINE ANHYDROUS) CODEINE PHOSPHATE10 mg  in 5 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
FD&C RED NO. 40 
ALCOHOL 
GLYCERIN 
POLYETHYLENE GLYCOLS 
POVIDONES 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SODIUM CITRATE 
SACCHARIN SODIUM 
SORBITOL 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58657-500-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34104/01/2014
Labeler - Method Pharmaceuticals, Inc. (078695281)

Revised: 4/2014
Document Id: bead5dd2-6b2a-46b4-8528-5dc727d0c884
Set id: fe126254-6ee6-48c3-965c-96e4276a5314
Version: 1
Effective Time: 20140408
 
Method Pharmaceuticals, Inc.