CHERATUSSIN DAC - codeine phosphate, guaifenesin and pseudoephedrine hydrochloride liquid 
Qualitest Pharmaceuticals

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Cheratussin DAC

CV

Active ingredients (in each 5 mL = 1 tsp)

Codeine phosphate, USP 10 mg

Guaifenesin, USP 100 mg

Pseudoephedrine HCl, USP 30 mg

Purpose

Cough suppressant

Expectorant

Nasal decongestant

Uses

• temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
• temporarily relieves nasal congestion due to the common cold
• temporarily restores freer breathing through the nose
• 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

• in a child under 2 years of age
• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
• 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 a doctor before use if you have

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to enlarged prostate gland
• 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 this product

• do not use more than directed
• constipation may occur or be aggravated

Stop use and ask a doctor if

• you get nervous, dizzy, or have trouble sleeping
• 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.

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 4 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, FD&C red #40, flavor, glycerin, menthol racemic, purified water, saccharin sodium, sodium benzoate, sorbitol solution

Made in the USA
for Qualitest Pharmaceuticals
Huntsville, AL 35811

Rev. 11/09 R8 8061410 1078

PRINCIPAL DISPLAY PANEL

CHERATUSSIN DAC  codeine phosphate and guaifenesin and pseudophedrine   liquid

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0603-1078 Route of Administration ORAL DEA Schedule CV

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CODEINE PHOSPHATE (CODEINE) CODEINE PHOSPHATE 10 mg  in 5 mL GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 100 mg  in 5 mL PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg  in 5 mL

Inactive Ingredients Ingredient Name Strength ALCOHOL   CARAMEL   FD&C RED NO. 40   GLYCERIN   MENTHOL   WATER   SACCHARIN SODIUM   SODIUM BENZOATE   SORBITOL

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

Packaging # NDC Package Description Multilevel Packaging 1 0603-1078-58 473 mL In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	01/01/1997

Labeler - Qualitest Pharmaceuticals (011103059)

Establishment
Name	Address	ID/FEI	Operations
Vintage Pharmaceuticals-Huntsville		958430845	MANUFACTURE

Revised: 12/2009Qualitest Pharmaceuticals