CODEINE-GUAIFENESIN- codeine phosphate and guaifenesin solution
Preferred 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.

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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

Cherry Flavor, Citric Acid, Glycerin,Masking flavor, Propylene glycol, Purified Water, Sodium Citrate, Sodium Benzoate, Sucralose Sorbitol.

Principal Display Panel

NDC 68788-7235-1
Codeine-Guaifenesin Oral Solution

10-100 mg/5 mL

Antitussive

Expectorant

Relabeled By: Preferred Pharmaceuticals Inc.

Guaifenesin & Codeine Oral Sol. 10-100mg/5mL

CODEINE-GUAIFENESIN
codeine phosphate and guaifenesin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68788-7235(NDC:58657-500)
Route of Administration	ORAL	DEA Schedule	CV

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)	CODEINE PHOSPHATE	10 mg in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68788-7235-1	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/07/2018	07/12/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	08/07/2018	07/12/2023

Labeler - Preferred Pharmaceuticals Inc. (791119022)

Registrant - Preferred Pharmaceuticals Inc. (791119022)

Name	Address	ID/FEI	Business Operations
Establishment
Preferred Pharmaceuticals Inc.		791119022	RELABEL(68788-7235)

Revised: 7/2023

Document Id: 3972e054-af71-45f7-97c1-7ddaba6837f6

Set id: bce452df-8fd2-439e-a778-cd599afc9cd6

Version: 6

Effective Time: 20230712

Preferred Pharmaceuticals Inc.