Your browser does not support JavaScript! GUAIFENESIN AC (GUAIFENESIN AND CODEINE PHOSPHATE) SYRUP [PACK PHARMACEUTICALS LLC]
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GUAIFENESIN AC (guaifenesin and codeine phosphate) syrup
[Pack Pharmaceuticals LLC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL CV OTC monograph final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections

INACTIVE INGREDIENTS

Alcohol 3.5%, artificial cherry flavor, caramel, citric acid, disodium edetate, FD&C Red #40, glycerin, purified water, saccharin sodium, sodium benzoate, sorbitol solution.

INDICATIONS

Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants. 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 6 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. Do not exceed recommended dosage.

WARNINGS

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 . 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. 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

Caution should be used when taking this product with sedatives, tranquilizers and drugs used for depression, especially monoamine oxidase inhibitors (MAOIs). These combinations may cause greater sedation (drowsiness) than is caused by the product used alone.

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.

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

PRINCIPAL DISPLAY PANEL - 473 mL Bottle

NDC 16571-302-16
TAMPER-EVIDENT
DO NOT REFRIGERATE

Guaifenesin AC CV
Cough Syrup

(GUAIFENESIN AND CODEINE
PHOSPHATE ORAL SOLUTION USP)

COUGH SUPPRESSANT • EXPECTORANT

Each teaspoon (5mL) contains:
Guaifenesin USP                  100 mg
Codeine Phosphate USP      10 mg
contains 3.5% alcohol v/v

*Under Federal law Guaifenesin AC
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  AC
guaifenesin and codeine phosphate syrup
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:16571-302
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
Inactive Ingredients
Ingredient NameStrength
Alcohol 
Cherry 
Caramel 
Citric Acid Monohydrate 
Edetate Disodium 
FD&C Red no. 40 
Glycerin 
Water 
Saccharin Sodium 
Sodium Benzoate 
Sorbitol 
Product Characteristics
ColorBROWNScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16571-302-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/22/2009
Labeler - Pack Pharmaceuticals LLC (614823875)

Revised: 9/2009
 
Pack Pharmaceuticals LLC

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