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R. A. McNeil Company

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FULL PRESCRIBING INFORMATION: CONTENTS*

• Drug Facts
  • Purpose
• M-END Uses
• Warnings
  • Do not use this product
  • Ask a doctor before use if you have
  • When using this product
  • Stop use and ask a doctor if
  • Keep out of reach of children.
• Directions
• M-END Other information
• Inactive ingredients
• Questions? Comments?
• Product Packaging

FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredients
(in each 5 mL teaspoonful)
Dexbrompheniramine Maleate 0.667 mg
Dextromethorphan HBr 10 mg
Pseudeophedrine HCl 20 mg

Purpose

Antihistamine
Antitussive
Cough Suppressant
Nasal Decongestant

M-END Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

• runny nose
• sneezing
• itching of the nose or throat
• itchy, watery eyes
• cough due to minor throat and bronchial irritation
• nasal congestion
• reduces swelling of nasal passages

Warnings

Do not exceed recommended dosage.

Do not use this product

• 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

• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• trouble urinating due to an enlarged prostate gland
• a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
• a cough that occurs with too much phlegm (mucus)
• heart disease
• high blood pressure
• thyroid disease
• diabetes
  

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product

• excitability may occur, especially in children
• may cause marked drowsiness
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizes may increase the drowsiness effect
• be careful when driving a motor vehicle or operating machinery
  

Stop use and ask a doctor if

• cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache.  A persistent cough may be a sign of a serious condition.
• nervousness, dizziness, or sleeplessness occur
• new symptoms occur
  

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.

Directions

M-END Other information

Store at 59°-86°F (15°-30°C)

Inactive ingredients

Bitter Mask, Citric Acid, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol, Sucralose, Tutti Frutti Flavor.

Questions? Comments?

Call 1-423-493-9170

Product Packaging

The packaging below represents the labeling currently used.

Principal display panel and side panel for 473 mL label:

NDC 12830-0816-16

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Antihistamine • Antitussive
• Nasal Decongestant

Alcohol Free • Gluten Free
Sugar Free • Dye Free

EACH 5 mL (1 TEASPOONFUL) CONTAINS:
Dexbrompheniramine Maleate.............0.667 mg
Dextromethorphan HBr...........................10 mg
Pseudoephedrine HCl.............................20 mg

Tutti-Frutti Flavor

ONE PINT (473 mL)

Mfg. for R.A. McNeil Company
Chattanooga, TN  37406-3738

Rev. 09/11

Tamper evident by foil seal under cap. Do not
use if foil seal is broken or missing.

THIS BOTTLE IS NOT TO BE DISPENSED TO
THE CONSUMER.

Dispense in a tight, light-resistant container
with a child resistant cap.

Manufactured for:
R.A. McNeil Company
1150 Latta Street
Chattanooga, TN  37406-3738

Rev. 09/11