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NDC 36800-0455-79 topcare 8 hr arthritis pain relief 650 mg/1 Details

topcare 8 hr arthritis pain relief 650 mg/1

topcare 8 hr arthritis pain relief is a ORAL TABLET, FILM COATED, 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: 36800-0455-79
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen

Product Information

NDC	36800-0455
Product ID	36800-455_b5b1ce8c-13d7-442f-8582-9bd75cdb884c
Associated GPIs	64200010000420
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	topcare 8 hr arthritis pain relief
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	Topco Associates LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA075077
Listing Certified Through	2024-12-31

Package

Package Images

NDC 36800-0455-79 (36800045579)

Pricing Information	N/A
NDC Package Code	36800-455-79
Billing NDC	36800045579
Package	1 BOTTLE in 1 CARTON (36800-455-79) / 400 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Marketing Start Date	2019-10-16
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a82f8818-1c22-46d0-b05f-698d2395ac48 Details

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 • 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)
•: do not use if printed foil under cap is broken or missing
•: meets the requirements of USP Dissolution Test 2

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, stearic acid, titanium dioxide

Questions or comments?

1-888-423-0139

Principal Display Panel

TopCare® health

COMPARE TO TYLENOL® 8HR ARTHRITIS PAIN ACTIVE INGREDIENT

8 HR Arthritis Pain Relief

ACETAMINOPHEN EXTENDED RELEASE TABLETS, 650 mg

PAIN RELIEVER • FEVER REDUCER

8 HOUR

For the Temporary Relief of Minor Arthritis Pain

actual size

24 CAPLETS† - 650 mg EACH

†CAPSULE-SHAPED TABLETS

INGREDIENTS AND APPEARANCE

TOPCARE 8 HR ARTHRITIS PAIN RELIEF

acetaminophen tablet, film coated, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-455
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
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code	L544
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:36800-455-78	1 in 1 CARTON	07/10/2018
1		100 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:36800-455-62	1 in 1 CARTON	07/10/2018
2		24 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:36800-455-71	1 in 1 CARTON	07/10/2018
3		50 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC:36800-455-79	1 in 1 CARTON	10/16/2019
4		400 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	ANDA075077	07/10/2018

Labeler - Topco Associates LLC (006935977)

Revised: 4/2022

Document Id: b5b1ce8c-13d7-442f-8582-9bd75cdb884c

Set id: a82f8818-1c22-46d0-b05f-698d2395ac48

Version: 4

Effective Time: 20220425