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NDC 36800-0770-02 Pain Relief 500 mg/1 Details

Pain Relief 500 mg/1

Pain Relief is a ORAL TABLET, COATED 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: 36800-0770-02
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen

Product Information

NDC	36800-0770
Product ID	36800-770_ee297186-69af-dc48-e053-2995a90a266b
Associated GPIs
GCN Sequence Number	059454
GCN Sequence Number Description	d-methorphan/PE/acetaminophen CAPSULE 10-5-325MG ORAL
HIC3	B4M
HIC3 Description	NON-OPIOID ANTITUSSIVE-DECONGESTANT-ANALGESIC COMB
GCN	25093
HICL Sequence Number	008885
HICL Sequence Number Description	DEXTROMETHORPHAN HBR/PHENYLEPHRINE HCL/ACETAMINOPHEN
Brand/Generic	Generic
Proprietary Name	Pain Relief
Proprietary Name Suffix	Extra Strength
Non-Proprietary Name	Acetaminophen
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, COATED
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 36800-0770-02 (36800077002)

Pricing Information	N/A
NDC Package Code	36800-770-02
Billing NDC	36800077002
Package	1 BOTTLE, PLASTIC in 1 CARTON (36800-770-02) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC
Marketing Start Date	2014-03-31
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ecd6df7e-e7e2-446b-85ef-25971281fe31 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each gelcap)

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 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 and children 12 years and over	take 2 gelcaps every 6 hours while symptoms last do not take more than 6 gelcaps 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 between 20-25ºC (68-77ºF)
retain carton for complete product information

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, D&C red #33, edible ink, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide

PRINCIPAL DISPLAY PANEL

NDC 36800-770-02

TopCare® Health

COMPARE TO EXTRA STRENGTH TYLENOL® RAPID RELEASE ACTIVE INGREDIENT†

Extra Strength

Pain Relief

ACETAMINOPHEN 500 mg

PAIN RELIEVER • FEVER REDUCER

For Adults

50 GELCAPS

INGREDIENTS AND APPEARANCE

PAIN RELIEF EXTRA STRENGTH

acetaminophen tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-770
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	gray (red and light blue ends)	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code	G1
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:36800-770-01	1 in 1 CARTON	03/31/2014	08/31/2023
1		24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC:36800-770-02	1 in 1 CARTON	03/31/2014
2		50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC:36800-770-03	1 in 1 CARTON	03/31/2014	08/31/2022
3		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4	NDC:36800-770-05	1 in 1 CARTON	03/31/2014	09/30/2022
4		225 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
5	NDC:36800-770-12	400 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2016	03/31/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	03/31/2014

Labeler - TopCo Associates LLC (006935977)

Revised: 11/2022

Document Id: ee297186-69af-dc48-e053-2995a90a266b

Set id: ecd6df7e-e7e2-446b-85ef-25971281fe31

Version: 6

Effective Time: 20221123