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NDC 51660-0333-50 Arthritis Pain Reliever 650 mg/1 Details

Arthritis Pain Reliever 650 mg/1

Arthritis Pain Reliever is a ORAL TABLET, FILM COATED, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by Ohm Laboratories Inc.. The primary component is ACETAMINOPHEN.

MedlinePlus Drug Summary

Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Related Packages: 51660-0333-50
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen

Product Information

NDC	51660-0333
Product ID	51660-333_1dcbcf53-1ec5-4cd7-af8d-b4eec5d3d0b9
Associated GPIs	64200010000420
GCN Sequence Number	022123
GCN Sequence Number Description	acetaminophen TABLET ER 650 MG ORAL
HIC3	H3E
HIC3 Description	ANALGESIC/ANTIPYRETICS,NON-SALICYLATE
GCN	16910
HICL Sequence Number	001866
HICL Sequence Number Description	ACETAMINOPHEN
Brand/Generic	Generic
Proprietary Name	Arthritis Pain Reliever
Proprietary Name Suffix	n/a
Non-Proprietary Name	Acetaminophen
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, FILM COATED, EXTENDED RELEASE
Route	ORAL
Active Ingredient Strength	650
Active Ingredient Units	mg/1
Substance Name	ACETAMINOPHEN
Labeler Name	Ohm Laboratories Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA076200
Listing Certified Through	2024-12-31

Package

Package Images

NDC 51660-0333-50 (51660033350)

Pricing Information
NDC Package Code	51660-333-50
Billing NDC	51660033350
Package	1 BOTTLE in 1 CARTON (51660-333-50) / 50 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Marketing Start Date	2002-04-30
NDC Exclude Flag	N
Price Per Unit	0.06921
Pricing Unit	EA
Effective Date	2024-02-21
NDC Description	ARTHRITIS PAIN ER 650 MG CAPLT
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 38b01bef-4743-4a25-b5c9-99f12133f373 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each caplet)

Acetaminophen USP, 650 mg

Purpose

Pain reliever/fever reducer

Uses

•

temporarily relieves minor aches and pains due to:

•: minor pain of arthritis
•: muscular aches
•: backache
•: premenstrual and menstrual cramps
•: the common cold
•: headache
•: toothache

•

temporarily reduces fever

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take

•: more than 6 caplets in 24 hours, which is the maximum daily amount
•: with other drugs containing acetaminophen
•: 3 or more alcoholic drinks every day while using this product

Allergy alert

acetaminophen may cause severe skin reactions. Symptoms may include:

•: skin reddening
•: blisters
•: rash

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

•: with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
•: if you are allergic to acetaminophen or any of the inactive ingredients in this product.

Ask a doctor before use if you have liver disease.

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Stop use and ask a doctor if

•: pain gets worse or lasts more than 10 days
•: fever gets worse or lasts more than 3 days
•: new symptoms occur
•: redness or swelling is present

These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Overdose warning

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

•: do not take more than directed (see overdose warning)

adults	• take 2 caplets every 8 hours with water • swallow whole; do not crush, chew, split or dissolve • do not take more than 6 caplets in 24 hours • do not use for more than 10 days unless directed by a doctor
under 18 years of age	• ask a doctor

Other information

•: store at 20 - 25° C (68 - 77° F). Avoid excessive heat 40° C (104° F).
•: see end panel for batch number and expiration date
•: TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.

Inactive ingredients

crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, stearic acid, titanium dioxide

Questions?

call 1-800-406-7984

SPL UNCLASSIFIED SECTION

Distributed by:

Ohm Laboratories Inc.

New Brunswick, NJ 08901

PRINCIPAL DISPLAY PANEL - 650 mg CAPLET Bottle Carton

NDC 51660-333-50

†Compare To the active ingredient of Tylenol® Arthritis Pain

Ohm®

Last up to 8 Hours

Use only as directed.

Arthritis Pain Relief

Acetaminophen

Extended-release Tablets USP, 650 mg

Pain Reliever/Fever Reducer

•: For the Temporary Relief of Minor Arthritis Pain

DO NOT USE WITH OTHER MEDICINES

CONTAINING ACETAMINOPHEN

50 CAPLETS* (*Capsule-Shaped Tablets)

Package/Label Principal Display Panel

NDC 51660-333-01

†Compare To the active ingredient of Tylenol® Arthritis Pain

Ohm®

Last up to 8 Hours

Use only as directed.

Arthritis Pain Relief

Acetaminophen

Extended-release Tablets USP, 650 mg

Pain Reliever/Fever Reducer

•: For the Temporary Relief of Minor Arthritis Pain

DO NOT USE WITH OTHER MEDICINES

CONTAINING ACETAMINOPHEN

100 CAPLETS* (*Capsule-Shaped Tablets)

Principal Display Panel

NDC 51660-333-24

†Compare To the active ingredient of Tylenol® Arthritis Pain

Ohm®

Last up to 8 Hours

Use only as directed.

Arthritis Pain Relief

Acetaminophen

Extended-release Tablets USP, 650 mg

Pain Reliever/Fever Reducer

•: For the Temporary Relief of Minor Arthritis Pain

DO NOT USE WITH OTHER MEDICINES

CONTAINING ACETAMINOPHEN

24 CAPLETS* (*Capsule-Shaped Tablets)

INGREDIENTS AND APPEARANCE

ARTHRITIS PAIN RELIEVER

acetaminophen tablet, film coated, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51660-333
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg

Ingredient Name	Strength
Inactive Ingredients
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STARCH, CORN (UNII: O8232NY3SJ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
CROSPOVIDONE (UNII: 2S7830E561)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code	cor116
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:51660-333-01	1 in 1 CARTON	04/30/2002
1		100 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:51660-333-50	1 in 1 CARTON	04/30/2002
2		50 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:51660-333-24	1 in 1 CARTON	09/03/2021
3		24 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076200	04/30/2002

Labeler - Ohm Laboratories Inc. (184769029)

Name	Address	ID/FEI	Business Operations
Establishment
Ohm Laboratories Inc.		184769029	MANUFACTURE(51660-333)

Revised: 11/2021

Document Id: 1dcbcf53-1ec5-4cd7-af8d-b4eec5d3d0b9

Set id: 38b01bef-4743-4a25-b5c9-99f12133f373

Version: 9

Effective Time: 20211104

Search by Drug Name or NDC

NDC 51660-0333-50 Arthritis Pain Reliever 650 mg/1 Details

Arthritis Pain Reliever 650 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 51660-0333-50 (51660033350)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 38b01bef-4743-4a25-b5c9-99f12133f373 Details

SPL UNCLASSIFIED SECTION

Active ingredient (in each caplet)

Purpose

Uses

Warnings

Liver warning

Allergy alert

Do not use

Stop use and ask a doctor if

Overdose warning

Directions

Other information

Inactive ingredients

Questions?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 650 mg CAPLET Bottle Carton

Package/Label Principal Display Panel

Principal Display Panel

INGREDIENTS AND APPEARANCE

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