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NDC 36800-0484-76 Topcare Pain Relief 500 mg/1 Details

Topcare Pain Relief 500 mg/1

Topcare Pain Relief is a ORAL TABLET 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: 36800-0484-76
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen

Product Information

NDC	36800-0484
Product ID	36800-484_250842b4-8344-4623-94ba-18c62ca4501c
Associated GPIs	64200010000315
GCN Sequence Number	004490
GCN Sequence Number Description	acetaminophen TABLET 500 MG ORAL
HIC3	H3E
HIC3 Description	ANALGESIC/ANTIPYRETICS,NON-SALICYLATE
GCN	16965
HICL Sequence Number	001866
HICL Sequence Number Description	ACETAMINOPHEN
Brand/Generic	Generic
Proprietary Name	Topcare Pain Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	Acetaminophen
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	500
Active Ingredient Units	mg/1
Substance Name	ACETAMINOPHEN
Labeler Name	Topco Associates LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part343
Listing Certified Through	2024-12-31

Package

Package Images

NDC 36800-0484-76 (36800048476)

Pricing Information	N/A
NDC Package Code	36800-484-76
Billing NDC	36800048476
Package	1 BOTTLE in 1 CARTON (36800-484-76) / 120 TABLET in 1 BOTTLE
Marketing Start Date	1987-07-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 6036c15b-1168-4103-9471-6a74a2140e53 Details

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

•: temporarily relieves minor aches and pains due to:
•: the common cold
•: headache
•: backache
•: minor pain of arthritis
•: toothache
•: muscular aches
•: premenstrual and menstrual cramps
•: temporarily reduces fever

Warnings

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

•: more than 4,000 mg of acetaminophen in 24 hours
•: 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 have ever had an allergic reaction to this product or any of its ingredients

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 and children 12 years and over	• take 2 caplets every 6 hours while symptoms last • 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
children under 12 years	ask a doctor

Other information

•: store at 20-25°C (68-77°F)

Inactive ingredients

carnauba wax, corn starch*, croscarmellose sodium*, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate*, stearic acid

*may contain one or more of these ingredients

Questions or comments?

1-888-423-0139

Principal Display Panel

TopCare® health

COMPARE TO EXTRA STRENGTH TYLENOL® CAPLETS ACTIVE INGREDIENT

EXTRA STRENGTH

Pain Relief

ACETAMINOPHEN 500 mg

PAIN RELIEVER • FEVER REDUCER

500 CAPLETS

For Adults

actual size

INGREDIENTS AND APPEARANCE

TOPCARE PAIN RELIEF

acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-484
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Ingredient Name	Strength
Inactive Ingredients
CARNAUBA WAX (UNII: R12CBM0EIZ)
STARCH, CORN (UNII: O8232NY3SJ)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	16mm
Flavor		Imprint Code	L484
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:36800-484-76	1 in 1 CARTON	07/15/1987
1		120 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:36800-484-62	1 in 1 CARTON	07/15/1987
2		24 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:36800-484-71	1 in 1 CARTON	07/15/1987
3		50 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC:36800-484-78	1 in 1 CARTON	07/15/1987
4		100 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC:36800-484-90	500 in 1 BOTTLE; Type 0: Not a Combination Product	07/15/1987
6	NDC:36800-484-82	2 in 1 CARTON	07/15/1987
6		100 in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC:36800-484-47	150 in 1 BOTTLE; Type 0: Not a Combination Product	07/15/1987

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	07/15/1987

Labeler - Topco Associates LLC (006935977)

Revised: 4/2022

Document Id: 250842b4-8344-4623-94ba-18c62ca4501c

Set id: 6036c15b-1168-4103-9471-6a74a2140e53

Version: 13

Effective Time: 20220412