Acetaminophen and Codeine (Page 5 of 5)

Dosage and Administration Section

Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [seeWARNINGS].
Important Dosage and Administration Instructions

Initiate the dosing regimen for each patient individually; taking into account the patient’s severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse [see WARNINGS].

Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy and following dosage increases with acetaminophen and codeine phosphate tablets and adjust the dosage accordingly [see WARNINGS].

Initial Dosage
Initiating Treatment with Acetaminophen and Codeine Phosphate Tablets

Dosage should be adjusted according to severity of pain and response of the patient. However, it should be kept in mind 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 are associated with an increased incidence of adverse reactions and are not associated with greater efficacy.

The usual adult dosage is:

Acetaminophen and Codeine Phosphate Tablets (codeine 15 mg and acetaminophen 300 mg): Take 1 to 2 tablets every 4 hours as needed for pain.

Acetaminophen and Codeine Phosphate Tablets (codeine 30 mg and acetaminophen 300 mg): Take 1 to 2 tablets every 4 hours as needed for pain.

Acetaminophen and Codeine Phosphate Tablets (codeine 60 mg and acetaminophen 300 mg): Take one tablet every 4 hours as needed for pain.

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 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.
The usual dose of codeine phosphate in children is 0.5 mg/kg. Doses may be repeated up to every 4 hours.


Conversion from Other Opioids to Acetaminophen and Codeine Phosphate Tablets
There is inter-patient variability in the potency of opioid drugs and opioid formulations. Therefore, a conservative approach is advised when determining the total daily dosage of Acetaminophen and Codeine Phosphate Tablets. It is safer to underestimate a patient’s 24-hour Acetaminophen and Codeine Phosphate Tablets dosage than to overestimate the 24-hour Acetaminophen and Codeine Phosphate Tablets dosage and manage an adverse reaction due to overdose.

Initiating Treatment with Acetaminophen and Codeine Phosphate Tablets


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.

Titration and Maintenance of Therapy

Individually titrate acetaminophen and codeine phosphate tablets to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving acetaminophen and codeine phosphate tablets to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse [seeWARNINGS]. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration.

If the level of pain increases after dosage stabilization, attempt to identify the source of increased pain before increasing the acetaminophen and codeine phosphate tablets dosage. If unacceptable opioid-related adverse reactions are observed, consider reducing the dosage. Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions.

Discontinuation of acetaminophen and codeine phosphate tablets

When a patient who has been taking acetaminophen and codeine phosphate tablets regularly and may be physically dependent no longer requires therapy with acetaminophen and codeine phosphate tablets,taper the dose gradually, by 25% to 50% every 2 to 4 days, while monitoring carefully for signs and symptoms of withdrawal. If the patient develops these signs or symptoms, raise the dose to the previous level and taper more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both. Do not abruptly discontinue Acetaminophen and Codeine Phosphate Tablets in a physically-dependent patient [see WARNINGS, DRUG ABUSE AND DEPENDENCE].

Please review the manufacturer’s complete drug information available from the FDA at www.fda.gov
Permanent Link: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=02386806-02d4-47e3-9c8b-7810146ee795

How Supplied Section

Acetaminophen and codeine phosphate tablets, USP are supplied as follows:

300 mg/30 mg

White to off-white, round, flat-faced, beveled-edged tablets, debossed with “U36” on one side and plain on the other side.

Bottles of 30 NDC 13107-059-30
Bottles of 100 NDC 13107-059-01
Bottles of 500 NDC 13107-059-05
Bottles of 1000 NDC 13107-059-99

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Keep this and all medication out of the reach of children.

Protect from moisture. Dispense in a tight, light-resistant container as described in the USP.

PROTECT FROM LIGHT

Dispense with Medication Guide availableat www.aurobindousa.com/product-medication-guides

Manufactured by:
Aurolife Pharma LLC
Dayton, NJ 08810

Manufactured for:
Aurobindo Pharma USA, Inc.
Dayton, NJ 08810

Revised: 12/2016
LM 2126

Bottles of 6 NDC: 51655-808-87

Bottles of 10 NDC: 51655-808-53

Bottles of 15 NDC: 51655-808-54

Bottles of 30 NDC: 51655-808-52

Repackaged for: Northwind Pharmaceuticals, LLC

Indianapolis, IN 46203


Please review the manufacturer’s complete drug information available from the FDA at www.fda.gov Permanent Link: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=02386806-02d4-47e3-9c8b-7810146ee795

Package Label.Principal Display Panel

NDC: 51655-808-54

Codeine Phosphate & APAP 30/300mg

15 Tablets

Lot:

Exp:

Store At: Store at 20C to 25C (68-77F)

Keep out of reach of children. Dosage: See package insert.

Manufactured By: Aurolife Pharma LLC

Manufacture Address: Dayton, NJ 08810

Manufacture NDC: 13107-059-99

Mfg Lot:

Distributed By: Northwind Pharmaceuticals Indianapolis, IN 46256

51655-808-54
(click image for full-size original)

NDC: 51655-808-52

Codeine Phosphate & APAP 30/300mg

30 Tablets

Lot:

Exp:

Store At: Store at 20C to 25C (68-77F)

Keep out of reach of children. Dosage: See package insert.

Manufactured By: Aurolife Pharma LLC

Manufacture Address: Dayton, NJ 08810

Manufacture NDC: 13107-059-99

Mfg Lot:

Distributed By: Northwind Pharmaceuticals Indianapolis, IN 46256

51655-808-52
(click image for full-size original)

NDC: 51655-808-53

Codeine Phosphate & APAP 30/300mg

10 Tablets

Lot:

Exp:

Store At: Store at 20C to 25C (68-77F)

Keep out of reach of children. Dosage: See package insert.

Manufactured By: Aurolife Pharma LLC

Manufacture Address: Dayton, NJ 08810

Manufacture NDC: 13107-059-99

Mfg Lot:

Distributed By: Northwind Pharmaceuticals Indianapolis, IN 46256

51655-808-53
(click image for full-size original)

NDC: 51655-808-87

Codeine Phosphate & APAP 30/300mg

6 Tablets

Lot:

Exp:

Store At: Store at 20C to 25C (68-77F)

Keep out of reach of children. Dosage: See package insert.

Manufactured By: Aurolife Pharma LLC

Manufacture Address: Dayton, NJ 08810

Manufacture NDC: 13107-059-99

Mfg Lot:

Distributed By: Northwind Pharmaceuticals Indianapolis, IN 46203

51655-808-87
(click image for full-size original)
ACETAMINOPHEN AND CODEINE acetaminophen and codeine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51655-808(NDC:13107-059)
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CODEINE PHOSPHATE (CODEINE ANHYDROUS) CODEINE PHOSPHATE 30 mg
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 300 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
CROSPOVIDONE (15 MPA.S AT 5%)
MAGNESIUM STEARATE
STARCH, CORN
SODIUM LAURYL SULFATE
STEARIC ACID
POVIDONE
Product Characteristics
Color white (White to Off White) Score no score
Shape ROUND (Flat-faced, Beveled Edge) Size 11mm
Flavor Imprint Code U36
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51655-808-54 15 TABLET in 1 BOTTLE None
2 NDC:51655-808-52 30 TABLET in 1 BOTTLE None
3 NDC:51655-808-87 6 TABLET in 1 BOTTLE None
4 NDC:51655-808-53 10 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202800 09/29/2016
Labeler — Northwind Pharmaceuticals (036986393)
Registrant — Northwind Pharmaceuticals (036986393)
Establishment
Name Address ID/FEI Operations
EPM Packaging 079124340 repack (51655-808)

Revised: 01/2020 Northwind Pharmaceuticals

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