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NDC 36800-0632-02 Arthritis Pain Relief 650 mg/1 Details

Arthritis Pain Relief 650 mg/1

Arthritis Pain Relief is a ORAL TABLET, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by TOPCO ASSOCIATES LLC. 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: 36800-0632-02
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen

Product Information

NDC	36800-0632
Product ID	36800-632_ea392a2b-465a-6a66-e053-2a95a90a62c8
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 Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	Acetaminophen
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, EXTENDED RELEASE
Route	ORAL
Active Ingredient Strength	650
Active Ingredient Units	mg/1
Substance Name	ACETAMINOPHEN
Labeler Name	TOPCO ASSOCIATES LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA211544
Listing Certified Through	2024-12-31

Package

Package Images

NDC 36800-0632-02 (36800063202)

Pricing Information	N/A
NDC Package Code	36800-632-02
Billing NDC	36800063202
Package	1 BOTTLE, PLASTIC in 1 CARTON (36800-632-02) / 50 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Marketing Start Date	2022-10-04
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e60aa992-f5f7-3506-e053-2995a90a7abd Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each caplet)

Acetaminophen 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, unless directed by a doctor do not use for more than 10 days unless directed by a doctor
under 18 years of age	ask a doctor

Other information

store between 20-25°C (68-77°F)
retain carton for complete product information and warnings

Inactive ingredients

hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

PRINCIPAL DISPLAY PANEL

TopCare® health

NDC 36800-632-02

COMPARE TO TYLENOL® 8HR ARTHRITIS PAIN ACTIVE INGREDIENT*

Arthritis Pain Relief

ACETAMINOPHEN EXTENDED-RELEASE TABLETS, 650 mg

PAIN RELIEVER • FEVER REDUCER

For the Temporary Relief of Minor Arthritis Pain

8 HOUR

actual size

50 CAPLETS** - 650 mg EACH ** CAPSULE SHAPED BI-LAYER TABLETS

INGREDIENTS AND APPEARANCE

ARTHRITIS PAIN RELIEF

acetaminophen tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-632
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
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE K30 (UNII: U725QWY32X)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE	Size	19mm
Flavor		Imprint Code	G650
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:36800-632-01	1 in 1 CARTON	10/04/2022
1		24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC:36800-632-02	1 in 1 CARTON	10/04/2022
2		50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC:36800-632-03	1 in 1 CARTON	10/04/2022
3		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4	NDC:36800-632-05	150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/04/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA211544	10/04/2022

Labeler - TOPCO ASSOCIATES LLC (006935977)

Revised: 10/2022

Document Id: ea392a2b-465a-6a66-e053-2a95a90a62c8

Set id: e60aa992-f5f7-3506-e053-2995a90a7abd

Version: 2

Effective Time: 20221004