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biclora-D (chlophedianol hydrochloride 25 mg / chlorcyclizine hydrochloride 25 mg / pseudoephedrine hydrochloride 60 mg) Dailymed

  1. Human OTC
  2. Archived
    • May Be Discontinued
      Try Other Labelers
  3. Hawthorn Pharmaceuticals, Inc.

Generic: chlophedional hydrochloride, chlorcyclizine hydrochloride, pseudoephedrine hydrochloride

biclora-D tablet - (chlophedianol hydrochloride 25 mg / chlorcyclizine hydrochloride 25 mg / pseudoephedrine hydrochloride 60 mg) image

IMPRINT: HAW 334     SHAPE: oval
    COLOR: white    SCORE: 2

  1. FDA Adverse Reactions

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Drug Facts


Active ingredients(in each tablet) Chlophedianol HCl 25 mgChlorcyclizine HCl 25 mgPseudoephedrine HCl 60 mg

Purpose


AntitussiveAntihistamineNasal 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

OTC - PREGNANCY OR BREAST FEEDING SECTION


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 children12 years of ageand over: 1 tablet every 6 to 8 hours,not to exceed 3 tablets in 24 hours, or as directedby a doctor.
Children 6 to under12 years of age: ½ tablet every 6 to 8 hours,not to exceed 1½ tablets in24 hours, or as directedby a doctor.
Children under 6years 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 mgChlorcyclizine HCl....................25 mgPseudoephedrine HCl...............60 mg For Professional Use The labeling for this product includes professional labeling which is not intendedfor the general public. PATENT PENDING HAWTHORNPHARMACEUTICALS, 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 ControlledRoom 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 APOISON CONTROL CENTER IMMEDIATELY. Patent Pending. Mfg for:  Hawthorn Pharmaceuticals, Inc.Madison, MS  39110        HL231  Rev. 11/12





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