BICLORA - chlorphedianol hydrochloride, chlorcyclizine 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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Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
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: | 1/2 tablet every 6 to 8 hours, not to exceed 1 1/2 tablets in 24 hours, or as directed by a doctor. |
Children under 6 years of age: | Consult a doctor. |
Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F). [See USP Controlled Room Temperature].
Biclora tablets are white to off white, biconvex, oval shaped tablets, debossed "HAW 332" on one side and bisect on the other side.
Colloidal Silicon Dioxide, Crospovidone, Magnesium Stearate, and Microcrystalline Cellulose.
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
HI283 Rev. 11/12
The packaging below represents the labeling currently used.
Principal display panel and side panel for 60 tablets label:
NDC 63717-332-06
biclora
TABLETS
Antitussive ∙ Antihistamine
Each tablet contains:
Chlopedianol Hydrochloride......................25 mg
Chlorcyclizine Hydrochloride....................25 mg
For Professional Use
The labeling for this product includes professional labeling which is not intended for use by 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 THE 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 HL230 Rev. 11/12
BICLORA
chlorphedianol hydrochloride, chlorcyclizine hydrochloride tablet |
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Labeler - Hawthorn Pharmaceuticals, Inc. (118049704) |