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Codeine Phosphate and Guaifenesin Prescribing Information

Package insert / product label
Dosage form: oral liquid
Drug class: Upper respiratory combinations

Medically reviewed by Drugs.com. Last updated on Mar 27, 2023.

Codeine Phosphate and Guaifenesin Description

Active ingredients (in each 5 mL teaspoonful)
Codeine Phosphate* 10 mg ..... Antitussive
*WARNING: May be habit forming
Guaifenesin 200 mg ..... Expectorant

Indications and Usage for Codeine Phosphate and Guaifenesin

· temporarily relieves these symptoms due to the common cold:
· cough due to minor throat and bronchial irritation
· helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive

Warnings

Do not exceed recommended dosage.
Do not use this product

· do not take this product if you have chronic pulmonary disease, shortness of breath,or children who are taking other drugs, unless directed by a doctor.

Ask a doctor before use if you have
· a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
· a cough that occurs with too much phlegm (mucus)

Stop use and ask a doctor if
· cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition.
· new symptoms occur
· may cause or aggravate constipation

If pregnant or breast-feeding,
ask a health professional before use.

Keep out of the reach of children.


In case of accidental overdose, seek professional assistance, or contact a Poison Control Center immediately.

Codeine Phosphate and Guaifenesin Dosage and Administration

Take this medication with a full glass of water after each dose to help loosen mucus in the lungs.

chart

Inactive ingredients

Cherry Flavor, Citric Acid, Glycerin, Menthol
Crystals, Propylene Glycol, Purified Water,
Sodium Citrate, Sodium Saccharin, Sorbitol,
and Vanilla Flavor.

Other information
Store at 68° - 77° F (20° - 25° C)

Questions? Comments?

Call 1-866-934-6025
cv
Manufactured for:
Kylemore Pharmaceuticals, LLC
Port St. Joe, FL 32456
323-10 Rev. 12/09

PACKAGING:

Codeine Phosphate 10 mg Guaifenesin 200 mg labeling:

label

CODEINE PHOSPHATE GUAIFENESIN
codeine phosphate, guaifenesin liquid
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:49769-323
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE - UNII:Q830PW7520) CODEINE PHOSPHATE10 mg in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL (UNII: L7T10EIP3A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
Product Characteristics
Color Score
ShapeSize
FlavorCHERRY (cherry-vanilla) Imprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49769-323-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/01/201011/30/2012
Labeler - Kylemore Pharmaceuticals, LLC (831892471)