CODEINE GUAIFENESIN- codeine phosphate, guaifenesin solution

CODEINE GUAIFENESIN by

Drug Labeling and Warnings

CODEINE GUAIFENESIN by is a Otc medication manufactured, distributed, or labeled by Leading Pharma, LLC, Woodfield Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients                                                              Purpose

(in each teaspoonful (5 mL))

Codeine Phosphate USP 10 mg ................... Antitussive

Guaifenesin USP 100 mg ........................... 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

INDICATIONS & USAGE

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 the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.

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.

INFORMATION FOR PATIENTS

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

QUESTIONS

Manufactured For:

Leading Pharma, LLC

Fairfield, NJ 07004

Rev. 07/2019

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CODEINE GUAIFENESIN 
codeine phosphate, guaifenesin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69315-248
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
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: 69315-248-48	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/19/2019
2	NDC: 69315-248-12	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/19/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	12/19/2019

Labeler - Leading Pharma, LLC (079575060)

Registrant - Leading Pharma, LLC (079575060)

Establishment
Name	Address	ID/FEI	Business Operations
Woodfield Pharmaceuticals, LLC		079398730	manufacture(69315-248)