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ENDACOF(dihydrocodeine bitartrate, brompheniramine maleate,(五)
2013-08-26 23:46:08 来源: 作者: 【 】 浏览:3875次 评论:0
ith narcotic overdosage. Convulsions, cardiovascular collapse, and death may occur. A single case of acute rhabdomyolysis associated with an overdose of dihydrocodeine has been reported.

Recommended Treatment
Immediate treatment of an overdosage of ENDACOF-DH Oral Liquid includes support of cardiorespiratory function and measures to reduce drug absorption. Vomiting should be induced with syrup of ipecac, if the patient is alert and has adequate laryngeal reflexes. Oral activated charcoal should follow. The first dose should be accompanied by an appropriate cathartic. Gastric lavage may be necessary. Hypotension is usually hypovolemic and should be treated with fluids. Endotracheal intubation and artificial respiration may be necessary. The pure opioid antagonist naloxone or nalmefene is a specific antidote against respiratory depression that results from opioid overdose. Oipioid antagonists should not be given in the absence of clinically significant respiratory or circulatory depression secondary to opioid overdose. They should be administered cautiously to person who are known, or suspected to be, physically dependent on any opioid agonist including dihydrocodeine. IN such cases, an abrupt or complete reversal of opioid effects may precipitate an acute abstinence syndrome. The prescribing information for the specific opioid antagonist should be consulted for details of their proper use.

DOSAGE AND ADMINISTRATION1

Adults and children 12 years of age and older: 1 teaspoonful every 4 to 6 hours. Not to exceed 6 teaspoonfuls in a 24-hour period.

Children 6 to 12 years of age: 1/2 teaspoonful every 4 to 6 hours. Not to exceed 3 teaspoonfuls in a 24-hour period.

Not recommended for children under 6 years of age.
--------------------------------------------------------------------------------
1
In mild cases or in particularly sensitive patients, less frequent or reduced doses may be appropriate and adequate.
HOW SUPPLIED
A clear colored liquid with a cherry flavor supplied in 16 oz. bottles (NDC 68047-139-16).

Storage
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Store at 15°-30°C (59°-86°F) [see USP Controlled Room Temperature.] Protect from freezing.

Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.

Rx only

Manufactured by:
Deltex Pharmaceuticals, Inc.
Rosenberg, TX 77471

Distributed by:
Larken Laboratories, Inc.
Canton, MS 39046

Rev. 08/09

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
NDC 68047-139-16

ENDACOF - DH
Liquid

ANTITUSSIVE / DECONGESTANT / ANTIHISTAMINE
SUGAR FREE ∙ ALCOHOL FREE ∙ DYE FREE

Each teaspoonful (5 mL) contains:
Phenylephrine HCl............... 7.5 mg
Brompheniramine Maleate.... 4 mg
Dihydrocodeine Bitartrate..... 3 mg
*(WARNING-May be habit forming)

Rx Only

LARKEN
LABORATORIES

16 fl. oz. (473 mL)

ENDACOFDH
dihydrocodeine bitartrate, brompheniramine maleate, and phenylephrine hydrochloride liquid
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68047-139
Route of Administration ORAL DEA Schedule CV
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Streng

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