Robafen AC description, usages, side effects, indications, overdosage, supplying and lots more!

Robafen AC

Major Pharmaceuticals

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Robafen AC Cough Syrup

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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.

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 Type Human otc drug label Item Code (Source) NDC:0904-5065
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Guaifenesin GUAIFENESIN 100 mg
CODEINE PHOSPHATE CODEINE ANHYDROUS 10 mg

Inactive Ingredients

Ingredient Name Strength
ALCOHOL
CARAMEL
ANHYDROUS CITRIC ACID
EDETATE DISODIUM
FD&C RED NO. 40
GLYCERIN
SACCHARIN SODIUM DIHYDRATE
SODIUM BENZOATE
sorbitol
CHERRY
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0904-5065-16 473 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2002-10-11


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