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

Hydrocodone Bitartrate and Acetaminophen Tablets, USP 2.5 mg/500 mg





Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/325 mg





Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/500 mg





Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/325 mg





Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/500 mg





Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/650 mg





Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/750 mg





Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg





Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg





Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/650 mg





Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/660 mg





CLINICAL PHARMACOLOGY




PHARMACOKINETICS

Pharmacokinetics:


Hydrocodone:
OVERDOSAGE

Acetaminophen:
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:

Special Risk Patients:


Cough Reflex:



INFORMATION FOR PATIENTS





LABORATORY TESTS



DRUG INTERACTIONS




DRUG & OR LABORATORY TEST INTERACTIONS



CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

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:

Hydrocodone:


Acetaminophen:




Treatment:








DOSAGE & ADMINISTRATION



Hydrocodone Bitartrate and Acetaminophen Tablets, USP 2.5 mg/500 mg


Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/325 mg


Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/500 mg


Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/325 mg


Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/500 mg


Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/650 mg


Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/750 mg


Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg


Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg


Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/650 mg


Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/660 mg


HOW SUPPLIED

Hydrocodone Bitartrate and Acetaminophen Tablets, USP 2.5 mg/500 mg


Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/325 mg


Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/500 mg


Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/325 mg


Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/500 mg


Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/650 mg


Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/750 mg


Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg


Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg


Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/650 mg


Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/660 mg


STORAGE AND HANDLING












INACTIVE INGREDIENT

SILICON DIOXIDE
CROSCARMELLOSE SODIUM
CROSPOVIDONE
FD&C RED NO. 3
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE

STARCH, CORN
STEARIC ACID
SUCROSE

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:49349-671(NDC:0603-3890)
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
lactose monohydrate
MAGNESIUM STEARATE
cellulose, microcrystalline
povidone
STARCH, CORN
SODIUM LAURYL SULFATE
STEARIC ACID
FD&C RED NO. 40
FD&C YELLOW NO. 6
SUCROSE

Product Characteristics

Color Size Imprint Code Shape
white 14 mm 3604;V OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-671-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040655 2011-03-10


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