FDA Label for Broncomar

Otc - Active Ingredient

Acvtive ingredients: (in 10 ml)              Purpose

Acetaminophen 200 mg ............................. Analgesic

Dextromethorphan HBr 13.33 mg ................... Cough Suppressant

Guaifenesin 200 mg ................................... Expectorant

Phenylephrine HCl 5 mg ............................. Decongestant

Otc - Purpose

Purpose

Analgesic

Cough Suppressant

Expectorant

Decongestant

Indications & Usage

Uses

• For temporary relief of bronchial and nasal congestion
• Help loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough more productive.
• Teporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold

Warnings

Warnings

Do not exceed recommended dosage

Liver warning: This product contains Acetaminophen. Sever liver damage may occur if

• Adult takes more than 6 doses in 24 hours, which is the maximum daily amount
• Child takes more than 5 doses in 24 hours
• Taken with other drugs containing Acetaminophen
• Adult has 3 or more alcoholic drinks everyday while using this product
• Do not give to children under 3 years of age or use for more than 10 days unless directed by a physician

Otc - Do Not Use

Do not use

• If you are now taking a prescription monoamine oxidase inhibitor (MAOI)( certain drugs for depression , psychiatric conditions, or Parkinson’s disease) or for 2 weeks after stopping the MAOI drug.
• if you do not know if your prescription drug contains on MAOI ask your doctor or pharmacist before taking this product
• if you have a chronic pulmonary disease or shortness of breath unless directed by a doctor
• avoid alcoholic beverages while you are taking this product
• do not use with any other drug containing Acetaminophen (prescirption or nonprescription). If you are not sure whether a drug contains Acetaminophen, ask a doctor or a pharmacist.

Ask the doctor before use if you have

• cough that occurs with too much phlegm (mucus)
• cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
• heart disease, high blood pressure, thyroid disease, or difficulty in urination due to the enlargement of prostate gland.
• The user has liver disease
• The user is taking the blood thinning drug Warfarin.

Otc - Stop Use

Stop use and ask the doctor if

• Nervoisness, dizziness or sleeplessness occurs.
• Cough persists for more than 1 week, tends to recur, or accompanied by fever, rash or persistent headache. A persistent cough may be sign of a serious condition

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use. 

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions

• Do not take more than 6 doses in any 24-hour period

Age                                                                        Dose

Adults and children 12 years and over           10 mL (2 tsps) every 6 hours

Children 6 to under 12 years of age.               5 mL (1 tsps) every 6 hours

Children under 6 years of age                       Do not use

Inactive Ingredient

Inactive ingredients

Aloe vera, citric acid, disodium EDTA, FD&C Red #40, hydroxyethyl cellulose, natural strawberry flavor, propylene glycol, water, sodium benzoate, sorbitol 70%, sucralose

Package Label.Principal Display Panel

BroncomarEx - broncomarex