BICLORA-D
- chlophedianol hydrochloride, chlorcyclizine hydrochloride and pseudoephedrine 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-D
Drug Facts
Active ingredients
(in each tablet)
Chlophedianol HCl 25 mg
Chlorcyclizine HCl 25 mg
Pseudoephedrine HCl 60 mg
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
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
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: | ½ tablet every 6 to 8 hours, not to exceed 1½ 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 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 mg
Chlorcyclizine HCl....................25 mg
Pseudoephedrine HCl...............60 mg
For Professional Use
The labeling for this product includes professional labeling which is not intended
for 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 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 HL231 Rev. 11/12
| BICLORA-D
chlophedional hydrochloride, chlorcyclizine hydrochloride, pseudoephedrine hydrochloride tablet |
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| Labeler - Hawthorn Pharmaceuticals, Inc. (118049704) |
| Registrant - Pernix Manufacturing, LLC (078641814) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Pernix Manufacturing, LLC dba Great Southern Laboratories | 078641814 | manufacture(63717-334) | |