BICLORA - chlorphedianol hydrochloride, chlorcyclizine 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

Drug Facts

Active ingredients
(in each tablet)

Chlophedianol HCl 25 mg
Chlorcyclizine HCl 25 mg

Purpose

Antitussive
Antihistamine

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, water eyes

Warnings


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

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

  • cough 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:


1/2  tablet every 6 to 8
hours, not to exceed 1 1/2
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 to 15° - 30°C (59° - 86°F).  [See USP Controlled Room Temperature].
Biclora tablets are white to off white, biconvex, oval shaped tablets, debossed "HAW 332" 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

HI283  Rev. 11/12

Product Packaging

The packaging below represents the labeling currently used.

Principal display panel and side panel for 60 tablets label:

NDC 63717-332-06

biclora
TABLETS

Antitussive Antihistamine

Each tablet contains:
Chlopedianol Hydrochloride......................25 mg
Chlorcyclizine Hydrochloride....................25 mg

For Professional Use
The labeling for this product includes professional labeling which is not intended for use by 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 THE 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             HL230  Rev. 11/12

biclora TABLETS Packaging


biclora TABLETS Packaging
BICLORA 
chlorphedianol hydrochloride, chlorcyclizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63717-332
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Chlophedianol Hydrochloride (UNII: 69QQ58998Y) (Chlophedianol - UNII:42C50P12AP) Chlophedianol Hydrochloride25 mg
Chlorcyclizine Hydrochloride (UNII: NPB7A7874U) (Chlorcyclizine - UNII:M26C4IP44P) Chlorcyclizine Hydrochloride25 mg
Inactive Ingredients
Ingredient NameStrength
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
Magnesium Stearate (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
Product Characteristics
Colorwhite (white to off white) Score2 pieces
ShapeOVALSize11mm
FlavorImprint Code HAW;332
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63717-332-0660 in 1 BOTTLE; Type 0: Not a Combination Product11/30/201210/23/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/30/201210/23/2014
Labeler - Hawthorn Pharmaceuticals, Inc. (118049704)

Revised: 12/2017
 
Hawthorn Pharmaceuticals, Inc.