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NDC 68071-1552-05 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 NuCare Pharmaceuticals,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: 68071-1552-05
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen

Product Information

NDC	68071-1552
Product ID	68071-1552_d6ac3eab-1724-33f5-e053-2995a90a748c
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
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	NuCare Pharmaceuticals,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 68071-1552-05 (68071155205)

Pricing Information	N/A
NDC Package Code	68071-1552-5
Billing NDC	68071155205
Package	50 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68071-1552-5)
Marketing Start Date	2017-09-29
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 5a5a4040-535d-54ac-e053-2991aa0aa4ab Details

ACTIVE INGREDIENT (IN EACH CAPLET)

Acetaminophen USP, 650 mg

PURPOSE

Pain reliever/fever reducer

USES (WHITE)

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

USES (RED)

temporarily relieves minor aches and pains due to:
- muscular aches
- backache
- minor pain of arthritis
- toothache
- premenstrual and menstrual cramps
- headache
- the common cold
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 (WHITE)

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

DIRECTIONS (RED)

do not take more than directed (see overdose warning)

Adults and children 12 years and over:

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

Children under 12 years:

do not use

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 (WHITE)

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

INACTIVE INGREDIENTS (RED)

croscarmellose sodium, D&C red no. 30 aluminum lake, FD&C yellow no. 6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, stearic acid, titanium dioxide

QUESTIONS?

call 1-800-406-7984

Contains No Aspirin

Keep the carton. It contains important information.

0115

Distributed by:

Ohm Laboratories Inc.

1385 Livingston Avenue

North Brunswick, NJ 08902

Principal Display Panel

INGREDIENTS AND APPEARANCE

ARTHRITIS PAIN RELIEVER

acetaminophen tablet, film coated, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68071-1552(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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (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)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68071-1552-5	50 in 1 BOTTLE; Type 0: Not a Combination Product	09/29/2017

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

Labeler - NuCare Pharmaceuticals,Inc. (010632300)

Name	Address	ID/FEI	Business Operations
Establishment
NuCare Pharmaceuticals,Inc.		010632300	relabel(68071-1552)

Revised: 1/2022

Document Id: d6ac3eab-1724-33f5-e053-2995a90a748c

Set id: 5a5a4040-535d-54ac-e053-2991aa0aa4ab

Version: 3

Effective Time: 20220128