Medication Guide App

Robafen AC

Dosage form: syrup
Ingredients: GUAIFENESIN 100mg in 5mL, CODEINE PHOSPHATE 10mg in 5mL
Labeler: Major Pharmaceuticals
NDC Code: 0904-5065

Disclaimer: 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.

Robafen AC Cough Syrup

Active ingredient

Each teaspoonful (5 mL) contains:

Guaifenesin USP    100 mg

Codeine Phosphate USP    10 mg

Contains 3.5% alcohol v/v

Purpose

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

Use

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

Warning

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 dirrected 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 reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

UNDER FEDERAL LAW ROBAFEN AC IS AVAILABLE WITHOUT A PRESCRIPTION. CERTAIN STATE LAWS MAY DIFFER.

For external use only

Do not use

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 directled by a doctor.

Ask a doctor before use if you have

If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.

When using this product

Drug Interaction Precaustion:

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

Stop use and ask a doctor if

Stop use and ask a doctor if cough persists for more than 1 week, tends to recur or is accompanied by fever, rash or presistent headache. 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 by a doctor,

Pregnancy/breast-feeding warning

As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

Keep out of reach of children

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

Directions

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 teaspoonfuls.

Children 6 to under 12 years of age: Give 1 teaspoonful.

Not intended for children under 6 years of age. Giving a higher dose than recommended by a doctor

could result n serious side effects for your child. Do not exceed recommended dosage.

Other information

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 to 25 degrees C (68 to 77 degrees F). Do not refrigerate.

Inactive ingredients

Inactive Ingredients:

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

Questions?

To report adverse drug events call (800) 616-2471

ROBAFEN AC SYRUP - 16 oz

Each teaspoonful (5 mL) contains:

Guaifenesin USP.........  100 mg

Codeine Phosphate USP........  10 mg

contains 3.5% acohol v/v

ROBAFEN AC 
guaifenesin and codeine phosphate syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5065
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 
CARAMEL 
ANHYDROUS CITRIC ACID 
EDETATE DISODIUM 
FD&C RED NO. 40 
GLYCERIN 
SACCHARIN SODIUM DIHYDRATE 
SODIUM BENZOATE 
SORBITOL 
CHERRY 
WATER 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0904-5065-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34110/11/2002
Labeler - Major Pharmaceuticals (191427277)

Revised: 04/2012
 
Major 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
(web1)