GUAIFENESIN DAC- guaifenesin, codeine phosphate and pseudoephedrine hydrochloride liquid  
Pack Pharmaceuticals LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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GUAIFENESIN DAC ORAL SOLUTION

INACTIVE INGREDIENTS

Alcohol 1.9%, artificial cherry flavor, caramel, citric acid, disodium edetate, FD&C Red #40, glycerin, menthol, purified water, saccharin sodium, sodium benzoate, sorbitol solution.

INDICATIONS

Temporarily relieves cough and nasal congestion as may occur with a cold. Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

DIRECTIONS

Take every 4 hours or as directed by a doctor. Do not exceed 4 doses in 24 hours. Adults and children 12 years of age and over: Take 2 teaspoons. Children 6 to under 12 years of age: Give 1 teaspoon. Children under 6 years of age: Do not use. Giving a higher dose than recommended by a doctor could result in serious side effects for your child.

WARNINGS

Do not exceed recommended dosage.

Do not take this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor. Adults and children who have a chronic pulmonary disease or shortness of breath, or children who are taking other drugs, should not take this product unless directed by a doctor. Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor. A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor. If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor. If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor. May cause or aggravate constipation. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

DRUG INTERACTION PRECAUTION

Do not use this product 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 are uncertain whether your prescription drug contains a MAOI, consult a health professional before taking this product.

Dispense in a tight, light-resistant container as defined in the USP.

Store at controlled room temperature 20°-25°C (68°-77°F). (see USP Controlled Room Temperature) DO NOT REFRIGERATE.

OTHER INFORMATION

Each 5 mL contains: sodium 4 mg.

TAMPER-EVIDENT

Do not use this product if inner foil seal over the mouth of the bottle is cut, torn, broken or missing.

BULK CONTAINER - NOT FOR HOUSEHOLD USE.

PRINCIPAL DISPLAY PANEL - 473 mL Bottle

NDC 16571-301-16
TAMPER-EVIDENT
DO NOT REFRIGERATE

GUAIFENESIN DAC
ORAL SOLUTION
CV

EXPECTORANT
NASAL DECONGESTANT
COUGH SUPPRESSANT

Each teaspoon (5 mL) Contains:
Guaifenesin USP                                100 mg
Pseudoephedrine Hydrochloride USP  30 mg
Codeine Phosphate USP                      10 mg
contains 1.9% alcohol v/v

*Under Federal law Guaifenesin DAC
is available without a prescription.
Certain State laws may differ.

Manufactured by:
Bio-Pharm, Incorporated Levittown, PA 19057
Distributed by: PACK PHARMACEUTICALS, LLC
Buffalo Grove, IL 60089     REV 08/09

TO REPORT ADVERSE DRUG EVENTS CALL:
(866) 562-4597

ONE PINT (473 mL)

PACK
PHARMACEUTICALS, LLC

Principal Display Panel - 473 mL Bottle
GUAIFENESIN DAC 
guaifenesin, codeine phosphate and pseudoephedrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:16571-301
Route of AdministrationORALDEA ScheduleCV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (Guaifenesin) Guaifenesin100 mg  in 5 mL
Codeine Phosphate (Codeine) Codeine10 mg  in 5 mL
Pseudoephedrine Hydrochloride (Pseudoephedrine) Pseudoephedrine30 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Alcohol 
Caramel 
Citric Acid Monohydrate 
Edetate Disodium 
FD&C Red no. 40 
Glycerin 
Water 
Saccharin Sodium 
Sodium Benzoate 
Sorbitol 
Menthol 
Product Characteristics
ColorRED Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16571-301-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved other09/28/2009
Labeler - Pack Pharmaceuticals LLC (614823875)

Revised: 10/2009
Document Id: dd66d0d4-e525-494c-8d77-2a3e737fc9a1
Set id: c5b23fbe-c6ff-4238-9647-d20311bb3405
Version: 1
Effective Time: 20091009
 
Pack Pharmaceuticals LLC