CODEINE-GUAIFENESIN- codeine phosphate and guaifenesin solution 
Proficient Rx LP

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 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

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 71205-624-04

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)

71205-624-04
CODEINE-GUAIFENESIN 
codeine phosphate and guaifenesin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71205-624(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:71205-624-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product12/03/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/15/2020
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIBusiness Operations
Proficient Rx LP079196022RELABEL(71205-624)

Revised: 12/2021
Document Id: 20f35f9f-5f3b-4305-b9e4-ab9a8fae9c1d
Set id: 20f35f9f-5f3b-4305-b9e4-ab9a8fae9c1d
Version: 1
Effective Time: 20211201
 
Proficient Rx LP