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NDC 41163-0592-01 acetaminophen 500 mg/1 Details

acetaminophen 500 mg/1

acetaminophen is a ORAL TABLET, COATED in the HUMAN OTC DRUG category. It is labeled and distributed by UNFI. 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: 41163-0592-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen

Product Information

NDC	41163-0592
Product ID	41163-592_e8ce9208-e3cb-f34d-e053-2995a90aedf7
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	acetaminophen
Proprietary Name Suffix	n/a
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	UNFI
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 41163-0592-01 (41163059201)

Pricing Information	N/A
NDC Package Code	41163-592-01
Billing NDC	41163059201
Package	1 BOTTLE, PLASTIC in 1 CARTON (41163-592-01) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC
Marketing Start Date	2022-09-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e689c9e3-dd4d-c646-e053-2a95a90a4b6a 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

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 tablets every 6 hours while symptoms last swallow whole – do not crush, chew, or dissolve 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

acesulfame potassium, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

Questions or comments?

1-855-423-2630

PRINCIPAL DISPLAY PANEL

EQUALINE®

NDC 41163-592-01

compare to Extra Strength Tylenol® Coated Tablets active ingredient*

extra strength

acetaminophen coated tablets

pain reliever/fever reducer

for adults

sweet coated

100 tablets - 500 mg each

actual size

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN

acetaminophen tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41163-592
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
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
FD&C RED NO. 40 (UNII: WZB9127XOA)
ALUMINUM OXIDE (UNII: LMI26O6933)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POVIDONE (UNII: FZ989GH94E)
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	A92
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:41163-592-01	1 in 1 CARTON	09/15/2022
1		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	09/15/2022

Labeler - UNFI (006961411)

Revised: 9/2022

Document Id: e8ce9208-e3cb-f34d-e053-2995a90aedf7

Set id: e689c9e3-dd4d-c646-e053-2a95a90a4b6a

Version: 2

Effective Time: 20220916