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NDC 68084-0777-25 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 American Health Packaging. 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: 68084-0777-25
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen

Product Information

NDC	68084-0777
Product ID	68084-777_e0e00d71-fc23-d450-e053-2a95a90a4f7a
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	American Health Packaging
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA076200
Listing Certified Through	2024-12-31

Package

Package Images

NDC 68084-0777-25 (68084077725)

Pricing Information
NDC Package Code	68084-777-25
Billing NDC	68084077725
Package	30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-777-25) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68084-777-95)
Marketing Start Date	2014-08-18
NDC Exclude Flag	N
Price Per Unit	0.06921
Pricing Unit	EA
Effective Date	2024-02-21
NDC Description	ACETAMINOPHEN ER 650 MG TABLET
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 ac5b24a4-39a8-4c8a-b293-5f59966fb444 Details

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° to 25°C (68° to 77°F). Avoid excessive heat 40°C (104°F).
FOR YOUR PROTECTION: Do not use if blister is torn or broken.
supplied as unit dose packages of 30 (5 x 6) NDC 68084-777-25

Inactive ingredients

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

Questions?

about the drug product, call Sun Pharmaceutical Industries, Inc. at 1-800-406-7984
about the packaging, call American Health Packaging at 1-800-707-4621

Contains No Aspirin

PACKAGING INFORMATION

American Health Packaging unit dose blisters contain drug product from Ohm Laboratories Inc. as follows:

(650 mg / 30 UD) NDC 68084-777-25 packaged from NDC 51660-333

Distributed by:

American Health Packaging

Columbus, OH 43217

8277725/0121

Principal Display Panel – Carton – 650 mg

NDC 68084- 777-25

Acetaminophen

Extended-release Tablets, USP

Pain Reliever/Fever Reducer

650 mg

30 Tablets (5 x 6)

DO NOT USE WITH OTHER MEDICINES

CONTAINING ACETAMINOPHEN.

Drug Facts

Active Ingredient Purpose

(in each caplet)

Acetaminophen USP, 650 mg ................. Pain reliever/fever reducer

Uses

See package insert for complete Drug Facts information.

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.

Keep out of reach of children.

See package insert for additional Drug Facts warnings.

Directions

• do not take more than directed, see package insert for

overdose warning and complete Drug Facts information.

Other Information • store at 20° to 25°C (68° to 77°F).

Avoid excessive heat 40°C (104°F). • FOR YOUR

PROTECTION: Do not use product if blister is torn or broken.

Contains No Aspirin

The drug product contained in this package is

from NDC # 51660-333, Ohm Laboratories Inc.

Distributed by: American Health Packaging

2550 John Glenn Avenue, Suite A

Columbus, OH 43217

077725

0277725/0222

Principal Display Panel – Blister – 650 mg

Acetaminophen

Extended-release

Tablet, USP

Pain Reliever/

Fever Reducer

650 mg

INGREDIENTS AND APPEARANCE

ARTHRITIS PAIN RELIEVER

acetaminophen tablet, film coated, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68084-777(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
CROSPOVIDONE (UNII: 2S7830E561)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:68084-777-25	30 in 1 BOX, UNIT-DOSE	08/18/2014
1	NDC:68084-777-95	1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076200	08/18/2014

Labeler - American Health Packaging (929561009)

Name	Address	ID/FEI	Business Operations
Establishment
American Health Packaging		929561009	repack(68084-777)

Revised: 6/2022

Document Id: e0e00d71-fc23-d450-e053-2a95a90a4f7a

Set id: ac5b24a4-39a8-4c8a-b293-5f59966fb444

Version: 7

Effective Time: 20220607

Search by Drug Name or NDC

NDC 68084-0777-25 Arthritis Pain Reliever 650 mg/1 Details

Arthritis Pain Reliever 650 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 68084-0777-25 (68084077725)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL ac5b24a4-39a8-4c8a-b293-5f59966fb444 Details

Drug Facts

Purpose

Uses

Warnings

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Directions

Other information

Inactive ingredients

Questions?

Principal Display Panel – Carton – 650 mg

Principal Display Panel – Blister – 650 mg

INGREDIENTS AND APPEARANCE

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