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



CLINICAL PHARMACOLOGY




PHARMACOKINETICS









CLINICAL STUDIES



INDICATIONS & USAGE



HYDROCODONE BITARTRATE AND ACETAMINOPHEN CONTRAINDICATIONS

WARNINGS-Anaphylactoid ReactionsPRECAUTIONS-Pre-existing Asthma

WARNINGS

DRUG ABUSE AND DEPENDENCE






CONTRAINDICATIONSPRECAUTIONS-Pre-existing Asthma
PRECAUTIONS-Renal Effects


PRECAUTIONS






WARNINGS-Advanced Renal Disease








INFORMATION FOR PATIENTS



LABORATORY TESTS

PRECAUTIONS-Hematological EffectsPRECAUTIONS-Hepatic Effects

DRUG INTERACTIONS







PRECAUTIONS-Renal Effects




CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY




PREGNANCY





LABOR & DELIVERY




NURSING MOTHERS




PEDIATRIC USE




GERIATRIC USE





HYDROCODONE BITARTRATE AND ACETAMINOPHEN ADVERSE REACTIONS

DOSAGE AND ADMINISTRATION

























DRUG ABUSE AND DEPENDENCE






OVERDOSAGE








DOSAGE & ADMINISTRATION

DOSAGE AND ADMINISTRATION


HOW SUPPLIED



STORAGE AND HANDLING











INACTIVE INGREDIENT

INACTIVE INGREDIENTS

CARNAUBA WAX

SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
STARCH, CORN
TITANIUM DIOXIDE

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:49349-689(NDC:53746-109)
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 15 mm IP;109 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-689-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040736 2011-03-16


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