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NDC 00363-0104-12 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 Walgreen Company. 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: 00363-0104-12
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen

Product Information

NDC	00363-0104
Product ID	0363-0104_b97354f4-7d01-45a7-9728-10af31b6597b
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	Walgreen Company
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 00363-0104-12 (00363010412)

Pricing Information	N/A
NDC Package Code	0363-0104-12
Billing NDC	00363010412
Package	1 BOTTLE in 1 BOX (0363-0104-12) / 100 TABLET in 1 BOTTLE
Marketing Start Date	1990-07-13
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ef4f915d-2dbf-4afe-8fc5-6bdd916df361 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 arthritis
- 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 4,000 mg of acetaminophen in 24 hours
child takes more than 5 doses in 24 hours
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
redness or swelling is present
pain gets worse or lasts more than 5 days in children under 12 years
new symptoms occur
fever gets worse or last more than 3 days

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.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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

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 take 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 take for more than 5 days unless directed by a doctor
children under 6 years	ask a doctor

Other information

store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
see end flap for expiration date and lot number

Inactive ingredients

corn starch, povidone, sodium starch glycolate, stearic acid

Questions or comments?

1-800-426-9391

Principal Display Panel

Walgreens

Compare to Tylenol® Regular Strength

Tablets active ingredient††

NDC 0363-0104-12

Pain Reliever

ACETAMINOPHEN 325 mg / PAIN RELIEVER / FEVER REDUCER

REGULAR STRENGTH TABLETS

100 TABLETS

ACTUAL SIZE

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

Walgreens Pharmacist Recommended

Walgreens Pharmacist Survey

††This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Tylenol® Regular Strength Tablets.

50844 ORG041710412

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

walgreens.com ©2018 Walgreen Co.

Walgreens 44-104

INGREDIENTS AND APPEARANCE

PAIN RELIEVER REGULAR STRENGTH

acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0104
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
STARCH, CORN (UNII: O8232NY3SJ)
POVIDONE (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	white	Score	2 pieces
Shape	ROUND	Size	10mm
Flavor		Imprint Code	44;104
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0363-0104-12	1 in 1 BOX	07/13/1990	06/17/2023
1		100 in 1 BOTTLE; 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	07/13/1990	06/17/2023

Labeler - Walgreen Company (008965063)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(0363-0104)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	manufacture(0363-0104)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(0363-0104)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	pack(0363-0104)

Revised: 10/2021

Document Id: b97354f4-7d01-45a7-9728-10af31b6597b

Set id: ef4f915d-2dbf-4afe-8fc5-6bdd916df361

Version: 14

Effective Time: 20211018