Biclora
FDA Label NDC 54868-6381

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Physicians Total Care, Inc. for the product Biclora (NDC 54868-6381). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, purpose, uses, ask a doctor before use if you have, otc - ask doctor/pharmacist, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active ingredients(in each 5 mL teaspoonful)Chlophedianol Hydrochloride 12.5 mgChlorcyclizine Hydrochloride 12.5 mg

Purpose

AntitussiveAntihistamine

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

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

Otc - Ask Doctor/Pharmacist

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, contact1-888-455-5253.Manufactured for:Hawthorn Pharmaceuticals,Madison, MS  39110HI282 Rev. 12/11

Product Packaging

The packaging below represents the labeling currently used.Principal display panel for 8 fl oz. label:NDC 54868-6381-0biclora LIQUIDAntitusive · AntihistamineEach teaspoonful (5 mL) contains:Chlophedianol HCl.......................12.5 mgChlorcyclizine HCl.......................12.5 mgFor professional use.The labeling for this product includes professional labelingwhich is not intended for use by the general public.Patent PendingAlcohol Free · Dye FreeCherry FlavorHAWTHORNPHARMACEUTICALS, INC.8 fl oz (240 mL)Distributed by:Physicians Total Care, Inc.Tulsa, OK        74146

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