BICLORA-D - chlophedianol hydrochloride, chlorcyclizine hydrochloride and pseudoephedrine hydrochloride liquid
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.

----------

biclora-D Liquid

Drug Facts

Active ingredients
(in each 5 mL teaspoonful)
Chlophedianol Hydrochloride 12.5 mg
Chlorcyclizine Hydrochloride 12.5 mg
Pseudoephedrine Hydrochloride 30 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 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.
Use a calibrated measuring device for administering the drug to a child.

Adults and children 12 years of age and over:	2 teaspoonfuls (10 mL) every 6 to 8 hours, not to exceed 6 teaspoonfuls in 24 hours, or as directed by a doctor.
Children 6 to under 12 years of age:	1 teaspoonful (5 mL) every 6 to 8 hours, not to exceed 3 teaspoonfuls 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].

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)

BICLORA-D
chlophedianol hydrochloride, chlorcyclizine hydrochloride, pseudoephedrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:63717-333
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Chlophedianol Hydrochloride (Chlophedianol)	Chlophedianol Hydrochloride	12.5 mg in 5 mL
Chlorcyclizine Hydrochloride (Chlorcyclizine)	Chlorcyclizine Hydrochloride	12.5 mg in 5 mL
Pseudoephedrine Hydrochloride (Pseudoephedrine)	Pseudoephedrine Hydrochloride	30 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
Citric Acid Monohydrate
Glycerin
Propylene Glycol
Water
Sodium Citrate
Sorbitol
Sucralose

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63717-333-08	240 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	10/08/2012

Labeler - Hawthorn Pharmaceuticals, Inc (118049704)

Registrant - Great Southern Laboratories (056139553)

Name	Address	ID/FEI	Business Operations
Establishment
Great Southern Laboratories		056139553	manufacture(63717-333)

Revised: 10/2012

Document Id: 224f98df-bad2-41d3-ba23-3733c55ec3e7

Set id: 57879b31-d547-487b-a9d3-c8d7ecd860ba

Version: 1

Effective Time: 20121010

Hawthorn Pharmaceuticals, Inc