GUAIFENESIN AND CODEINE PHOSPHATE solution

GUAIFENESIN and CODEINE PHOSPHATE by

Drug Labeling and Warnings

GUAIFENESIN and CODEINE PHOSPHATE by is a Otc medication manufactured, distributed, or labeled by QUAGEN PHARMACEUTICALS LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

• Active ingredients(in each 5 mL = 1 tsp):

  Purpose

• Codeine phosphate, USP 10 mg:

  Cough suppressant

• 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 make coughs 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.

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of the 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

Each tsp (5 mL) contains 3 mg sodium. 
Store at controlled room temperature 15°-30°C (59°-86°F). You may report side effects by calling 1-888-344-9603 or FDA at 1-800-FDA-1088.

Inactive ingredients

Caramel flavor, cherry flavor, citric acid, glycerin, peppermint flavor, purified water, sodium benzoate, sodium saccharin, sorbitol.

SPL UNCLASSIFIED SECTION

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

Manufactured by:
Quagen Pharmaceuticals LLC
West Caldwell, NJ 07006

MADE IN USA

PRINCIPAL DISPLAY PANEL-4 fl oz (118 mL) Container Label

PRINCIPAL DISPLAY PANEL-8 fl oz (237 mL) Container Label

PRINCIPAL DISPLAY PANEL-16 fl oz (473 mL) Container Label

INGREDIENTS AND APPEARANCE

GUAIFENESIN AND CODEINE PHOSPHATE 
guaifenesin and codeine phosphate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70752-180
Route of Administration	ORAL	DEA Schedule	CV

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

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color		Score
Shape		Size
Flavor	CARAMEL, CHERRY, PEPPERMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70752-180-06	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/23/2022
2	NDC: 70752-180-15	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/23/2022
3	NDC: 70752-180-12	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/23/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	05/23/2022

Labeler - QUAGEN PHARMACEUTICALS LLC (073645339)

Registrant - QUAGEN PHARMACEUTICALS LLC (073645339)

Establishment
Name	Address	ID/FEI	Business Operations
QUAGEN PHARMACEUTICALS LLC		080281331	manufacture(70752-180) , pack(70752-180)