CODEINE-GUAIFENESIN- codeine phosphate and guaifenesin solution
Quality Care Products, 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 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, Propylene glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.

image description

CODEINE-GUAIFENESIN
codeine phosphate and guaifenesin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55700-741(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 (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:55700-741-04	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/05/2019	11/30/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	04/05/2019	11/30/2021

Labeler - Quality Care Products, LLC (831276758)

Name	Address	ID/FEI	Business Operations
Establishment
Quality Care Products, LLC		831276758	relabel(55700-741)

Revised: 1/2022

Document Id: bef22fda-4d3b-480f-88be-5ace6832490b

Set id: 867c95a2-31d3-4450-bbfa-97433acaaad0

Version: 2

Effective Time: 20220113

Quality Care Products, LLC