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 TABLETS Packaging


biclora-D TABLETS Packaging





BICLORA-D  
chlophedional hydrochloride, chlorcyclizine hydrochloride, pseudoephedrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:63717-334
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Chlophedianol Hydrochloride (Chlophedianol) Chlophedianol Hydrochloride25 mg
Chlorcyclizine Hydrochloride (Chlorcyclizine) Chlorcyclizine Hydrochloride25 mg
Pseudoephedrine Hydrochloride (Pseudoephedrine) Pseudoephedrine Hydrochloride60 mg
Inactive Ingredients
Ingredient NameStrength
Silicon Dioxide 
Crospovidone 
Magnesium Stearate 
Cellulose, Microcrystalline 
Product Characteristics
Colorwhite (white to off white) Score2 pieces
ShapeOVALSize11mm
FlavorImprint Code HAW;334
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63717-334-0660 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/30/201211/30/2014
Labeler - Hawthorn Pharmaceuticals, Inc. (118049704)
Registrant - Pernix Manufacturing, LLC (078641814)
Establishment
NameAddressID/FEIBusiness Operations
Pernix Manufacturing, LLC dba Great Southern Laboratories078641814manufacture(63717-334)

Revised: 12/2013
 
Hawthorn Pharmaceuticals, Inc.