BICLORA  - chlophedianol hydrochloride, chlorcyclizine hydrochloride liquid 
Physicians Total Care, 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 Liquid

Drug Facts

Active ingredients
(in each 5 mL teaspoonful)

Chlophedianol Hydrochloride 12.5 mg
Chlorcyclizine Hydrochloride 12.5 mg

Purpose

Antitussive
Antihistamine

Uses

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

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

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 to 15°-30°C (59°-86°F).
[See USP Controlled Room Temperature].

Inactive ingredients

Cherry Flavor, Citric Acid, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sorbitol, Sucralsoe.

Questions? Comments?

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

Manufactured for:
Hawthorn Pharmaceuticals,
Madison, MS  39110
HI282 Rev. 12/11

Product Packaging

The packaging below represents the labeling currently used.

Principal display panel for 8 fl oz. label:

NDC 54868-6381-0

biclora Liquid Packaging


biclora LIQUID

Antitusive · Antihistamine

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

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

Patent Pending

Alcohol Free · Dye Free

Cherry Flavor

HAWTHORN
PHARMACEUTICALS, INC.

8 fl oz (240 mL)


Distributed by:
Physicians Total Care, Inc.
Tulsa, OK        74146
BICLORA  
chlophedianol hydrochloride, chlorcyclizine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-6381(NDC:63717-331)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Chlophedianol Hydrochloride (UNII: 69QQ58998Y) (Chlophedianol - UNII:42C50P12AP) Chlophedianol Hydrochloride12.5 mg  in 5 mL
Chlorcyclizine Hydrochloride (UNII: NPB7A7874U) (Chlorcyclizine - UNII:M26C4IP44P) Chlorcyclizine Hydrochloride12.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
Glycerin (UNII: PDC6A3C0OX)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Water (UNII: 059QF0KO0R)  
Sodium Citrate (UNII: 1Q73Q2JULR)  
Sorbitol (UNII: 506T60A25R)  
Sucralose (UNII: 96K6UQ3ZD4)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54868-6381-0240 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/02/2013
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIBusiness Operations
Physicians Total Care, Inc.194123980relabel(54868-6381)

Revised: 1/2013
Document Id: 56e02cdd-dd44-419f-896c-9db80dc2f6f4
Set id: c588736a-250b-4fc6-b221-b4b51052b032
Version: 1
Effective Time: 20130102
 
Physicians Total Care, Inc.