Hydrocodone Bitartrate and Acetaminophen description, usages, side effects, indications, overdosage, supplying and lots more!

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Hydrocodone Bitartrate and Acetaminophen

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

HYDROCODONE BITARTRATE AND ACETAMINOPHEN DESCRIPTION




Hydrocodone Bitartrate and Acetaminophen


Hydrocodone Bitartrate and Acetaminophen


Product StrengthHydrocodone Bitartrate USPAcetaminophen USP





CLINICAL PHARMACOLOGY




PHARMACOKINETICS


OVERDOSAGE
OVERDOSAGE

INDICATIONS & USAGE



HYDROCODONE BITARTRATE AND ACETAMINOPHEN CONTRAINDICATIONS




WARNINGS

Respiratory Depression


Head Injury and Increased Intracranial Pressure


Acute Abdominal Conditions


Misuse, Abuse, and Diversion of Opioids

DRUG ABUSE AND DEPENDENCE

PRECAUTIONS

General



INFORMATION FOR PATIENTS





LABORATORY TESTS



DRUG INTERACTIONS




DRUG & OR LABORATORY TEST INTERACTIONS



CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY



PREGNANCY

Teratogenic Effects:Pregnancy Category C


Nonteratogenic Effects


LABOR & DELIVERY



NURSING MOTHERS



PEDIATRIC USE



GERIATRIC USE





HYDROCODONE BITARTRATE AND ACETAMINOPHEN ADVERSE REACTIONS






OVERDOSAGE



OVERDOSAGE

DRUG ABUSE AND DEPENDENCE

Misuse, Abuse, and Diversion of Opioids






OVERDOSAGE



Signs and Symptoms:





Treatment








DOSAGE & ADMINISTRATION



Product StrengthUsual Adult Dosage AS NEEDED FOR PAINThe total daily dosage should not exceed


HOW SUPPLIED






























































STORAGE AND HANDLING




PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Hydrocodone Bitartrate and Acetaminophen

Hydrocodone Bitartrate and Acetaminophen

Hydrocodone Bitartrate and Acetaminophen

Hydrocodone Bitartrate and Acetaminophen TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-357(NDC:57664-126)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
HYDROCODONE BITARTRATE HYDROCODONE 5 mg
ACETAMINOPHEN ACETAMINOPHEN 325 mg

Inactive Ingredients

Ingredient Name Strength
CROSCARMELLOSE SODIUM
CROSPOVIDONE
MAGNESIUM STEARATE
cellulose, microcrystalline
povidone
STARCH, CORN
STEARIC ACID

Product Characteristics

Color Size Imprint Code Shape
white 14 mm 126 BULLET

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-357-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090118 2011-07-08


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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