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Codeine Phosphate and Guaifenesin

Medically reviewed on January 17, 2017

Dosage form: liquid
Ingredients: CODEINE PHOSPHATE 10mg in 5mL, GUAIFENESIN 100mg in 5mL
Labeler: Noble Pharmaceuticals, LLC
NDC Code: 70156-112

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 Phosphate and Guaifenesin

CV

Active ingredients (in each teaspoonful (5 mL))

Codeine phosphate USP 10 mg

Guaifenesin USP 100 mg

Purpose

Antitussive (Cough Suppressant)

Expectorant

Uses
  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants
  • relieves 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
  • temporarily relieves cough associated with the common cold

Warnings

Ask your Doctor if:

  • you have a persistent or chronic cough, this may be a sign of a serious condition
  • you have a persistent or chronic 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, 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 20° to 25°C (68° to 77°F)

Inactive ingredients

Cherry flavor, citric acid, ededate disodium, FD&C red #40, glycerin, maltodextrin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol, sucralose

Question or Comments
Please call 1-888-514-4727

Marketed by: Noble Pharmaceuticals, LLC
Cooper City, FL 33024

PRINCIPAL DISPLAY PANEL
CODEINE PHOSPHATE AND GUAIFENESIN 
codeine phosphate and guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70156-112
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 
EDETATE DISODIUM 
FD&C RED NO. 40 
GLYCERIN 
MALTODEXTRIN 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
TRISODIUM CITRATE DIHYDRATE 
SORBITOL 
SUCRALOSE 
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:70156-112-04118 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34101/17/2017
Labeler - Noble Pharmaceuticals, LLC (080006461)
Establishment
NameAddressID/FEIOperations
BioRamo, LLC968948443MANUFACTURE(70156-112)

 
Noble Pharmaceuticals, LLC

← See all Codeine Phosphate and Guaifenesin brands

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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