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NDC 63868-0083-60 Pain Relief 500 mg/1 Details

Pain Relief 500 mg/1

Pain Relief is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Chain Drug Marketing Association. 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: 63868-0083-60
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen

Product Information

NDC	63868-0083
Product ID	63868-083_7e490b7b-e78e-5917-e053-2991aa0a3d17
Associated GPIs	64200010000315
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	Pain Relief
Proprietary Name Suffix	Extra Strength
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	Chain Drug Marketing Association
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 63868-0083-60 (63868008360)

Pricing Information	N/A
NDC Package Code	63868-083-60
Billing NDC	63868008360
Package	1 BOTTLE, PLASTIC in 1 CARTON (63868-083-60) / 60 TABLET in 1 BOTTLE, PLASTIC
Marketing Start Date	2014-06-13
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 2619d6b9-9941-4b1f-9c2e-3e8d5caac28d Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

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

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 tablets every 6 hours while symptoms last do not take more than 6 tablets 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 20-25°C (68-77°F)
retain carton for complete product information

Inactive ingredients

povidone, pregelatinized starch, sodium starch glycolate, stearic acid

PRINCIPAL DISPLAY PANEL

NDC 63868-083-60

QUALITY CHOICE

†Compare to the Active Ingredient in TYLENOL® Extra Strength Tablets

Extra Strength

Pain Relief

Pain Reliever / Fever Reducer

Acetaminophen, 500 mg

60 Tablets – 500 mg each

INGREDIENTS AND APPEARANCE

PAIN RELIEF EXTRA STRENGTH

acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63868-083
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
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	M2A4;57344
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63868-083-60	1 in 1 CARTON	06/13/2014
1		60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC:63868-083-10	1 in 1 CARTON	06/13/2014
2		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	06/13/2014

Labeler - Chain Drug Marketing Association (011920774)

Revised: 12/2018

Document Id: 7e490b7b-e78e-5917-e053-2991aa0a3d17

Set id: 2619d6b9-9941-4b1f-9c2e-3e8d5caac28d

Version: 2

Effective Time: 20181230