Brom/PSE/DM

Macoven Pharmaceuticals

Brom/PSE/DM Cough Syrup

FULL PRESCRIBING INFORMATION: CONTENTS*

• Brom/PSE/DM Uses
• Warnings
  • Ask a doctor before use if you have
  • Ask a doctor or pharmacist before use
  • When using this product
  • Stop use and ask a doctor if
  • Keep out of reach of children.
• Directions
• Brom/PSE/DM Other information
• Inactive ingredients
• Questions?
• PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Brom/PSE/DM Uses

temporarily relieves

• runny nose
• sneezing
• itching of the nose and throat
• itching, watery eyes due to hay fever or other upper respiratory allergies
• nasal congestion due to the common cold
• cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
• the impulse to cough to help you get to sleep

Warnings

• may cause excitability, or increased irritability especially in children
• Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

• heart disease
• diabetes
• glaucoma
• thyroid disease
• high blood pressure
• trouble urinating due to enlarged prostate gland
• persistent or chronic cough such as occurs with emphysema, chronic bronchitis or asthma
• cough accompanied by too much phlegm (mucus)

Ask a doctor or pharmacist before use

• if you or your child are taking sedatives or tranquilizers

When using this product

• marked drowsiness may occur
• do not exceed recommended dosage
• avoid alcoholic drinks
• be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occurs
• symptoms do not get better within 7 days, come back or occur with a fever, rash, or persistent headache. These could be signs of a serious illness.

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

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. 800-222-1222

Directions

• take every 4 hours
• do not take more than 4 doses in 24 hours or as directed by a doctor

Do Not Use in Children under 4 years of age

Brom/PSE/DM Other information

Store at 25°C (77°F): Excursions permitted to 15°-30°C (59°-86°F) (See USP Controlled Temperature)

• Tamper Evident: Do not use if seal is broken or missing.
• Protect from freezing.

Inactive ingredients

Alcohol Dehydrated, Butter Scotch Flavor, Citric Acid Anhydrous, FD&C Red #40, Glycerin, High Fructose Corn Syrup, Methyl Paraben, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate Dihydrate.

Questions?

Call 1-877-622-6836

Manufactured for: Macoven Pharmaceuticals, LLC
Magnolia, TX 77354

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC 44183-220-16

Brom/PSE/DM
Cough Syrup

ANTIHISTAMINE, NASAL DECONGESTANT,
COUGH SUPPRESSANT

Butter Scotch Flavor

16 fl. oz. (473 mL)

MACOVEN
PHARMACEUTICALS