biclora-D

Hawthorn Pharmaceuticals, Inc
Great Southern Laboratories

biclora-D Liquid

FULL PRESCRIBING INFORMATION: CONTENTS*

• Drug Facts
  • Purpose
• biclora-D 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
• biclora-D Other information
• Inactive ingredients
• Questions? Comments?
• Product Packaging

FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredients

(in each 5 mL teaspoonful)

Chlopedianol Hydrochloride 12.5 mg

Chlorcyclizine Hydrochloride 12.5 mg

Pseudoephedrine Hydrochloride 30 mg

Purpose

Antitussive

Antihistamine

Nasal Decongestant

biclora-D Uses

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

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

Warnings

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 cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
• a cough that occurs with too much phlegm (mucus)
• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• difficulty in urination due to the enlargement of the prostate gland
• 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 tranquilizers may increase the drowsiness effect
• be careful when driving a motor vehicle or operating machinery
  

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• 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.
• 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 immediately.

Directions

Do not exceed recommended dosage.

Use calibrated measuring device for administering the drug to a child.

biclora-D Other information

Store at 20° - 25°C (68° - 77°F); excursions permitted 15° - 30°C (59° - 86°F).  [See USP Controlled Room Temperature].

Inactive ingredients

Citric Acid, Glycerin, Grape Flavor, Propylene Glycol, Purified Water, Sodium Citrate, Sorbitol, Sucralose.

Questions? Comments?

To report a serious adverse event or obtain product information, contact 1-888-455-5253.

Manufactured for:
Hawthorn Pharmaceuticals,
Madison, MS  39110

HI281 Rev. 12/11

Product Packaging

The packaging below represents the labeling currently used.

Principal display panel for 8 fl oz. label:

NDC 63717-333-08

biclora-D LIQUID

Antitussive · Antihistamine
·Nasal Decongestant

Each teaspoonful (5 mL) contains:
Chlophedianol HCl...........................12.5 mg
Chlorcyclizine HCl...........................12.5 mg
Pseudoephedrine HCl.........................30 mg

For professional use.
The labeling for this product includes professional labeling
which is not intended for use by the general public.

Patent Pending

Grape Flavor

Alcohol Free · Dye Free

HAWTHORN
PHARMACEUTICALS, INC.

8 fl oz (240 mL)