CHERATUSSIN AC- codeine phosphate and guaifenesin liquid

Drug Labeling and Warnings

Drug Details [pdf]

Active ingredients (in each 5 mL = 1 tsp)

Codeine phosphate, USP 10 mg

Guaifenesin, USP 100 mg

Purpose

Cough suppressant

Expectorant

Uses

• temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
• helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
• calms the cough control center and relieves coughing

Warnings

DO NOT USE

Do not use

• in a child under 2 years of age
• if you or your child has a chronic pulmonary disease or shortness of breath
• if your child is taking other drugs, unless directed by a doctor

ASK DOCTOR

Ask a doctor before use if you have

• cough that occurs with excessive phlegm (mucus)
• cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

WHEN USING

When using this product constipation may occur or be aggravated

STOP USE

Stop use and ask a doctor if cough lasts more than 7 days, comes back or is accompanied by fever, rash, or persistent headache. These could be signs 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

• take every 4 hours
• do not take more than 6 doses in any 24-hour period

• adults and children 12 years and over:

  take 10 mL (2 tsp)

• children 6 years to under 12 years:

  take 5 mL (1 tsp)

• children 2 years to under 6 years:

  consult a doctor

• children under 2 years:

  do not use

Attention: A special measuring device should be used to give an accurate dose of this product to children under 6 years of age. Giving a higher dose than recommended by a doctor could result in serious side effects for your child.

Other information

store at 15° to 30°C (59° to 86°F)

You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

Inactive ingredients

alcohol, caramel, citric acid, FD&C red #40, flavor, glycerin, menthol racemic, purified water, saccharin sodium, sodium benzoate, sorbitol solution

SPL UNCLASSIFIED SECTION

Made in the USA
for Qualitest Pharmaceuticals
Huntsville, AL 35811

Rev. 1/15 R7 8081202 1075

HOW SUPPLIED

Product: 50090-0423

NDC: 50090-0423-0 118 mL in a BOTTLE, PLASTIC

codeine phosphate and guaifenesin

INGREDIENTS AND APPEARANCE

CHERATUSSIN AC 
codeine phosphate and guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50090-0423(NDC: 0603-1075)
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
ALCOHOL (UNII: 3K9958V90M)
CARAMEL (UNII: T9D99G2B1R)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)

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: 50090-0423-0	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/28/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	09/01/1996

Labeler - A-S Medication Solutions (830016429)

Establishment
Name	Address	ID/FEI	Business Operations
A-S Medication Solutions		830016429	RELABEL(50090-0423)