BICLORA-D - chlophedianol hydrochloride, chlorcyclizine hydrochloride and pseudoephedrine hydrochloride tablet
Hawthorn Pharmaceuticals, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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biclora-D

Drug Facts

Active ingredients
(in each tablet)
Chlophedianol HCl 25 mg
Chlorcyclizine HCl 25 mg
Pseudoephedrine HCl 60 mg

Purpose

Antitussive
Antihistamine
Nasal Decongestant

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 the 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 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.

Adults and children 12 years of age and over:	1 tablet every 6 to 8 hours, not to exceed 3 tablets in 24 hours, or as directed by a doctor.
Children 6 to under 12 years of age:	½ tablet every 6 to 8 hours, not to exceed 1½ tablets in 24 hours, or as directed by a doctor.
Children under 6 years of age:	Consult a doctor.

Other information

Store at 20° - 25° C (68° - 77°F); excursions permitted 15° - 30° C (59° - 86°F). [See USP Controlled Room Temperature]. Biclora-D tablets are white to off white, biconvex, oval shaped tablets, debossed "HAW 334" on one side and bisect on the other side.

Inactive ingredients

Colloidal Silicon Dioxide, Crospovidone, Magnesium Stearate, and Microcrystalline Cellulose.

Questions? Comments?

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

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

Manufactured for:
Hawthorn Pharmaceuticals,
Madison, MS 39110 HI284 Rev. 11/12

Product Packaging

The packaging below represents the labeling currently used.

Principal display panel and side panel for 60 tablets label:

NDC 63717-334-06

biclora-D
TABLETS

Antitussive · Antihistamine · Nasal Decongestant

Each tablet contains:
Chlophedianol HCl....................25 mg
Chlorcyclizine HCl....................25 mg
Pseudoephedrine HCl...............60 mg

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

PATENT PENDING

HAWTHORN
PHARMACEUTICALS, INC.

60 tablets

Usual Dosage: See Drug Facts for full dosage information.

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

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.

KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN.
IN CASE OF OVERDOSE, GET MEDICAL HELP OR CONTACT A
POISON CONTROL CENTER IMMEDIATELY.

Patent Pending.

Mfg for: Hawthorn Pharmaceuticals, Inc.
Madison, MS 39110 HL231 Rev. 11/12

BICLORA-D
chlophedional hydrochloride, chlorcyclizine hydrochloride, pseudoephedrine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:63717-334
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Chlophedianol Hydrochloride (Chlophedianol)	Chlophedianol Hydrochloride	25 mg
Chlorcyclizine Hydrochloride (Chlorcyclizine)	Chlorcyclizine Hydrochloride	25 mg
Pseudoephedrine Hydrochloride (Pseudoephedrine)	Pseudoephedrine Hydrochloride	60 mg

Ingredient Name	Strength
Inactive Ingredients
Silicon Dioxide
Crospovidone
Magnesium Stearate
Cellulose, Microcrystalline

Product Characteristics
Color	white (white to off white)	Score	2 pieces
Shape	OVAL	Size	11mm
Flavor		Imprint Code	HAW;334
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63717-334-06	60 in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	11/30/2012

Labeler - Hawthorn Pharmaceuticals, Inc. (118049704)

Registrant - Pernix Manufacturing, LLC (078641814)

Name	Address	ID/FEI	Business Operations
Establishment
Pernix Manufacturing, LLC dba Great Southern Laboratories		078641814	manufacture(63717-334)

Revised: 9/2012

Document Id: 3f541d79-00f3-4e2d-ae99-ed17e625c65c

Set id: ff6d610d-a1a7-4bf9-bb31-80f46673e784

Version: 1

Effective Time: 20120927

Hawthorn Pharmaceuticals, Inc.