ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS USP CIII

//ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS USP CIII
ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS USP CIII2018-09-11T14:34:33+00:00

Prescription Drug Name:

ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS USP CIII

ID:

57ee1a9a-25d6-41ea-b86c-b9cc5a8cebe6

Code:

34391-3

DESCRIPTION


id: 5735ab60-b676-4476-8b64-b775621515b3
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Acetaminophen and codeine is supplied in tablet form for oral administration. Acetaminophen, 4ʹ-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:

C8H9NO2                                   M.W. 151.16

Codeine phosphate, 7,8-didehydro-4,5α-epoxy-3-methoxy-17methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula:

C18H21NO3•H3PO4•½H2O                                 M.W. 406.37

Each tablet contains:

acetaminophen 300 mg
codeine phosphate 15 mg
(Warning: May be habit forming)
OR
acetaminophen 300 mg
codeine phosphate 30 mg
(Warning: May be habit forming)
OR
acetaminophen 300 mg
codeine phosphate 60 mg
(Warning: May be habit forming)
In addition, each tablet contains the following inactive ingredients: corn starch, NF; croscarmellose sodium, NF; magnesium stearate, NF; microcrystalline cellulose, NF; polyvinylpyrrolidone; sodium lauryl sulfate, NF; stearic acid, NF.

CLINICAL PHARMACOLOGY


id: e1e71713-1dcc-4b7c-b99b-add8897e79fb
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1

This product combines the analgesic effects of a centrally acting analgesic, codeine, with a peripherally acting analgesic, acetaminophen.

INDICATIONS AND USAGE


id: 892dac72-d30e-4f54-8e1d-9b4ee9f2325c
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Acetaminophen and codeine phosphate tablets are indicated for the relief of mild to moderately severe pain.

CONTRAINDICATIONS


id: b8977795-d37c-498f-a43c-0c8a26d2b45d
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Codeine-containing products are contraindicated for post-operative pain management in children who have undergone tonsillectomy and/or adenoidectomy. This product should not be administered to patients who have previously exhibited hypersensitivity to codeine or acetaminophen.

ADVERSE REACTIONS


id: e8b6716d-6104-4520-b7e6-3db17ce4c76f
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

The most frequently reported adverse reactions are drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea and vomiting. These effects seem to be more prominent in ambulatory than in non-ambulatory patients, and some of these adverse reactions may be alleviated if the patient lies down. Other adverse reactions include allergic reactions, euphoria, dysphoria, constipation, abdominal pain, pruritus, rash, thrombocytopenia, agranulocytosis. At higher doses codeine has most of the disadvantages of morphine including respiratory depression.

OVERDOSAGE


id: 55295182-c6f1-458d-977d-4fa264a676f4
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

Following an acute overdosage, toxicity may result from codeine or acetaminophen.

DOSAGE AND ADMINISTRATION


id: bf782f8a-160b-479b-b4d6-25d6da5a3324
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

Dosage should be adjusted according to severity of pain and response of the patient. The usual adult dosage is:

Single Doses (range) Maximum 24 Hour Dose
Codeine Phosphate 15 mg to 60 mg 360 mg
Acetaminophen 300 mg to 1000 mg 4000 mg
The usual dose of codeine phosphate in children is 0.5 mg/kg. Doses may be repeated up to every 4 hours. The prescriber must determine the number of tablets per dose, and the maximum number of tablets per 24 hours based upon the above dosage guidance. This information should be conveyed in the prescription. It should be kept in mind, however, that tolerance to codeine can develop with continued use and that the incidence of untoward effects is dose related. Adult doses of codeine higher than 60 mg fail to give commensurate relief of pain but merely prolong analgesia and are associated with an appreciably increased incidence of undesirable side effects. Equivalently high doses in children would have similar effects.

HOW SUPPLIED


id: 9c9227e9-2b9c-4da3-9a91-473c22c90387
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Acetaminophen and codeine phosphate tablets (300 mg/15 mg) white, round, unscored, debossed MP 111 on one side and 2 on the other side. Available as follows:

Bottles of 50 NDC 53489-159-02
Bottles of 100 NDC 53489-159-01
Bottles of 500 NDC 53489-159-05
Bottles of 1000 NDC 53489-159-10
Acetaminophen and codeine phosphate tablets (300 mg/30 mg) white, round, unscored, debossed MP 122 on one side and 3 on the other side. Available as follows:
Bottles of 50 NDC 53489-160-02
Bottles of 100 NDC 53489-160-01
Bottles of 500 NDC 53489-160-05
Bottles of 1000 NDC 53489-160-10
Acetaminophen and codeine phosphate tablets (300 mg/60 mg) white, round, unscored, debossed MP 127 on one side and 4 on the other side. Available as follows:
Bottles of 50 NDC 53489-161-02
Bottles of 100 NDC 53489-161-01
Bottles of 500 NDC 53489-161-05
Bottles of 1000 NDC 53489-161-10

PRINCIPAL DISPLAY PANEL – 300 mg/15 mg Bottle Label


id: ce164265-ba1c-41b8-b443-bd08a95b53db
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

MP NDC 53489-159-01 ACETAMINOPHEN
AND CODEINE
PHOSPHATE
TABLETS USP
CIII 300 mg/
15 mg
100 TABLETS
Rx only
MUTUAL PHARMACEUTICAL CO., INC.

PHILADELPHIA, PA 19124 USA

PRINCIPAL DISPLAY PANEL – 300 mg/30 mg Bottle Label


id: b282a32a-e8ee-4ddd-a7bb-9e930798fb98
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

MP NDC 53489-160-01 ACETAMINOPHEN
AND CODEINE
PHOSPHATE
TABLETS USP
CIII 300 mg/
30 mg
100 TABLETS
Rx only
MUTUAL PHARMACEUTICAL CO., INC.

PHILADELPHIA, PA 19124 USA

PRINCIPAL DISPLAY PANEL – 300 mg/60 mg Bottle Label


id: ec7b1b82-54b5-498b-96b9-fe777ab41cd6
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

MP NDC 53489-161-01 ACETAMINOPHEN
AND CODEINE
PHOSPHATE
TABLETS USP
CIII 300 mg/
60 mg
100 TABLETS
Rx only
MUTUAL PHARMACEUTICAL CO., INC.

PHILADELPHIA, PA 19124 USA