CODEINE-GUAIFENESIN- codeine phosphate and guaifenesin solution 
Westminster 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

Drug Facts

Active ingredients (in each 5 mL = 1 tsp)Purpose
Codeine phosphate, USP 10 mg  Antitussive
Guaifenesin, USP 100 mgExpectorant

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 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

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

You may report side effects by calling 1-844-221-7294 or FDA at 1-800-FDA-1088.

Inactive ingredients

Cherry Flavor, Citric Acid Anhydrous, Glycerin, Masking Agent, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate, Sorbitol Solution, Sucralose.

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

NDC 69367-272-04

Codeine-Guaifenesin
Oral Solution
10-100 mg/5 mL

Antitussive/Expectorant

Sugar Free, Alcohol Free, Dye Free

Each 5 mL (1 teaspoonful) contains:
Codeine phosphate, USP
10 mg
Guaifenesin, USP
100 mg

(WARNING: May be habit-forming)

4 fl. oz. (118 mL)

Westminster
Pharmaceuticals

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
CODEINE-GUAIFENESIN 
codeine phosphate and guaifenesin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69367-272
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 BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69367-272-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product07/15/2020
2NDC:69367-272-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product07/15/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/15/2020
Labeler - Westminster Pharmaceuticals, LLC (079516651)

Revised: 7/2020
Document Id: d45a9328-736e-46c2-9631-c38867b8972e
Set id: 3da3efd7-e278-4d79-9130-eef3992097e4
Version: 1
Effective Time: 20200716
 
Westminster Pharmaceuticals, LLC