Search by Drug Name or NDC

NDC 49035-0491-01 Pain Reliever 325 mg/1 Details

Pain Reliever 325 mg/1

Pain Reliever is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC). 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: 49035-0491-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen

Product Information

NDC	49035-0491
Product ID	49035-491_33bca576-5b63-4edc-839c-abfcb427b2ac
Associated GPIs	64200010000310
GCN Sequence Number	004489
GCN Sequence Number Description	acetaminophen TABLET 325 MG ORAL
HIC3	H3E
HIC3 Description	ANALGESIC/ANTIPYRETICS,NON-SALICYLATE
GCN	16964
HICL Sequence Number	001866
HICL Sequence Number Description	ACETAMINOPHEN
Brand/Generic	Generic
Proprietary Name	Pain Reliever
Proprietary Name Suffix	Regular Strength
Non-Proprietary Name	Acetaminophen
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	325
Active Ingredient Units	mg/1
Substance Name	ACETAMINOPHEN
Labeler Name	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part343
Listing Certified Through	n/a

Package

Package Images

NDC 49035-0491-01 (49035049101)

Pricing Information	N/A
NDC Package Code	49035-491-01
Billing NDC	49035049101
Package	1 BOTTLE, PLASTIC in 1 BOX (49035-491-01) / 100 TABLET in 1 BOTTLE, PLASTIC
Marketing Start Date	2015-10-31
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 028ec0f2-2da5-4b76-a48e-65640ef15405 Details

Active ingredient (in each tablet)

Acetaminophen 325 mg

Purpose

Pain reliever/ fever reducer

Uses

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

Warnings

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

adult takes more than 4000 mg of acetaminophen in 24 hours
child takes more than 5 doses in 24 hours, which is the maximum daily amount
taken with other drugs containing acetaminophen
adult has 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 the user has

liver disease.

Ask a doctor or pharmacist before use if the user is

taking the blood thinning drug warfarin.

Stop use and ask a doctor if

pain gets worse or lasts more than 10 days in adults
pain gets worse or lasts more than 5 days in children under 12 years
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 Contorl Center (1-800-222-1222) right away. 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 4 to 6 hours while symptoms last do not take more than 10 tablets in 24 hours do not use for more than 10 days unless directed by a doctor
children 6-11 years	take 1 tablet every 4 to 6 hours while symptoms last do not take more than 5 tablets in 24 hours do not use for more than 5 days unless directed by a doctor
children under 6 years	ask a doctor

Other information

store between 20-25ºC (68-77ºF)

Inactive ingredients

povidone, pregelatized starch, sodium starch glycolate*, stearic acid

*may contain this ingredient

Questions or comments?

Call 1-888-287-1915

Principal Display Panel

Compare to Tylenol® Regular Strength Active Ingredient†

Regular Strength

Pain Reliever

Acetaminophen

Pain Reliever/ Fever Reducer

For ages 6 years and over

Tablets

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY: Wal-Mart Stores, Inc.,

Bentonville, AR 72716

†This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Tylenol® Regular Strength.

Product Label

Equate Regular Strength Pain Reliever Tablets

INGREDIENTS AND APPEARANCE

PAIN RELIEVER REGULAR STRENGTH

acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49035-491
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 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	10mm
Flavor		Imprint Code	TCL340
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49035-491-01	1 in 1 BOX	10/31/2015	01/31/2025
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	10/31/2015	01/31/2025

Labeler - EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) (051957769)

Revised: 10/2022

Document Id: 33bca576-5b63-4edc-839c-abfcb427b2ac

Set id: 028ec0f2-2da5-4b76-a48e-65640ef15405

Version: 3

Effective Time: 20221025