Skip to Content

Guaifenesin AC

Dosage form: syrup
Ingredients: Guaifenesin 100mg in 5mL, Codeine Phosphate 10mg in 5mL
Labeler: Rising Pharmaceuticals
NDC Code: 16571-302

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.

Guaifenesin AC

Each teaspoon (5 mL) Contains:
Guaifenesin USP100 mg
Codeine Phosphate USP10 mg

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.

WARNINGS

Do not exceed recommended dosage. 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. Do not use in children following a tonsillectomy and/or adenoidectomy as this could cause severe respiratory distress.

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.

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

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.

Manufactured by:
Bio-Pharm, Incorporated Levittown, PA 19057

Distributed by:
Rising Pharmaceuticals, Inc. Allendale, NJ 07401

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

Rising® NDC 16571-302-16

Guaifenesin AC
Cough Syrup

CV

SUGAR-FREE

GUAIFENESIN AND CODEINE
PHOSPHATE ORAL SOLUTION, USP)
COUGH SUPPRESSANT
EXPECTORANT

Each teaspoon (5 mL) 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:
Rising Pharmaceuticals, Inc. Allendale, NJ 07401

TAMPER-EVIDENT
DO NOT REFRIGERATE

ONE PINT (473 mL)

GUAIFENESIN AC 
guaifenesin and codeine phosphate syrup
Product Information
Product TypeHUMAN OTC DRUGItem 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 Anhydrous) Codeine Phosphate10 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 Description
1NDC:16571-302-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER03/01/2015
Labeler - Rising Pharmaceuticals (835513529)
Establishment
NameAddressID/FEIOperations
Bio-Pharm, Inc.801652546MANUFACTURE(16571-302), ANALYSIS(16571-302), PACK(16571-302), LABEL(16571-302)

Revised: 03/2015
 
Rising Pharmaceuticals

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide