CODEINE-GUAIFENESIN- codeine phosphate and guaifenesin solution

Codeine-Guaifenesin by

Drug Labeling and Warnings

Codeine-Guaifenesin by is a Otc medication manufactured, distributed, or labeled by Method Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

Principal Display Panel

NDC: 58657-500-16
Codeine-Guaifenesin Oral Solution
10-100 mg/5 mL
Antitussive
Expectorant
16 fl. oz. (473 mL)

INGREDIENTS AND APPEARANCE

CODEINE-GUAIFENESIN 
codeine phosphate and guaifenesin solution

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58657-500-04	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2014
2	NDC: 58657-500-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	04/01/2014

Labeler - Method Pharmaceuticals, LLC (060216698)

Establishment
Name	Address	ID/FEI	Business Operations
Monarch PCM, LLC		080000294	manufacture(58657-500)