CODEINE PHOSPHATE AND GUAIFENESIN liquid

Codeine Phosphate and Guaifenesin by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredients (in each teaspoonful (5 mL))

Codeine phosphate USP 10 mg

Guaifenesin USP 100 mg

Purpose

Antitussive (Cough Suppressant)

Expectorant

Uses

• temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants
• relieves 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
• temporarily relieves cough associated with the common cold

Warnings

ASK DOCTOR

Ask your Doctor if:

• you have a persistent or chronic cough, this may be a sign of a serious condition
• you have a persistent or chronic 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

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

Stop use and ask a doctor if

• symptoms do not improve within 7 days, tend to recur or are accompanied by fever, 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.

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 20° to 25°C (68° to 77°F)

Inactive ingredients

Cherry flavor, citric acid, ededate disodium, FD&C red #40, glycerin, maltodextrin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol, sucralose

SPL UNCLASSIFIED SECTION

Question or Comments
Please call 1-888-514-4727

Marketed by: Noble Pharmaceuticals, LLC
Cooper City, FL 33024

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CODEINE PHOSPHATE AND GUAIFENESIN 
codeine phosphate and guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70156-112
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)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70156-112-04	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/17/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	01/17/2017

Labeler - Noble Pharmaceuticals, LLC (080006461)

Establishment
Name	Address	ID/FEI	Business Operations
BioRamo, LLC		968948443	MANUFACTURE(70156-112)