Label: BICLORA- chlophedianol hydrochloride, chlorcyclizine hydrochloride liquid
Contains inactivated NDC Code(s)
NDC Code(s): 54868-6381-0
- Packager: Physicians Total Care, Inc.
- This is a repackaged label.
- Source NDC Code(s): 63717-331
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated January 2, 2013
If you are a consumer or patient please visit this version.
- Drug Facts
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
- itching of the nose or throat
- itchy, watery eyes
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
- difficulty in urination due to the enlargement of the prostate gland
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
Do not exceed recommended dosage.
Use a calibrated measuring device for administering the drug to a child.
Adults and children
12 years of age
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.
6 years of age:
Consult a doctor.
- Other information
- Inactive ingredients
- Questions? Comments?
The packaging below represents the labeling currently used.
Principal display panel for 8 fl oz. label:
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.
Alcohol Free · Dye Free
8 fl oz (240 mL)
Physicians Total Care, Inc.
Tulsa, OK 74146
INGREDIENTS AND APPEARANCE
chlophedianol hydrochloride, chlorcyclizine hydrochloride liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54868-6381(NDC:63717-331) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Chlophedianol Hydrochloride (UNII: 69QQ58998Y) (Chlophedianol - UNII:42C50P12AP) Chlophedianol Hydrochloride 12.5 mg in 5 mL Chlorcyclizine Hydrochloride (UNII: NPB7A7874U) (Chlorcyclizine - UNII:M26C4IP44P) Chlorcyclizine Hydrochloride 12.5 mg in 5 mL Inactive Ingredients Ingredient Name Strength 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 Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54868-6381-0 240 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/02/2013 Labeler - Physicians Total Care, Inc. (194123980) Establishment Name Address ID/FEI Business Operations Physicians Total Care, Inc. 194123980 relabel(54868-6381)