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 ATLANTIC BIOLOGICALS CORP.. 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

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP. 

20101 N.E 16TH PLACE 

MIAMI, FL 33179

PRINCIPAL DISPLAY PANEL

NDC: 17856-0208-1

CODEINE PHOSPHATE-GUAIFENESIN

ORAL SOL 10-100mg/mL CUP 72

INGREDIENTS AND APPEARANCE

CODEINE PHOSPHATE AND GUAIFENESIN 
codeine phosphate and guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17856-0208(NDC:54932-208)
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: 17856-0208-1	72 in 1 BOX, UNIT-DOSE	09/24/2018
1		5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	09/24/2018

Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)

Establishment
Name	Address	ID/FEI	Business Operations
ATLANTIC BIOLOGICALS CORP.		047437707	repack(17856-0208) , relabel(17856-0208)