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NDC 53329-0642-30 Medline Acetaminophen 325 mg/1 Details

Medline Acetaminophen 325 mg/1

Medline Acetaminophen is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Medline Industries, LP. 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: 53329-0642-30
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen

Product Information

NDC	53329-0642
Product ID	53329-642_d1040ffc-2529-3dfa-e053-2a95a90a79e7
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	Medline Acetaminophen
Proprietary Name Suffix	n/a
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	Medline Industries, LP
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 53329-0642-30 (53329064230)

Pricing Information	N/A
NDC Package Code	53329-642-30
Billing NDC	53329064230
Package	100 TABLET in 1 BOTTLE (53329-642-30)
Marketing Start Date	2013-12-26
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 46175721-4cf7-42d0-8ef0-2d51d695a49e Details

Tamper Evident Packaging

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

Active ingredient (in each tablet)

Acetaminophen USP, 325 mg

Purpose

Pain reliever/fever reducer

Uses

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

Warnings

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

adults take more than 4.000 mg 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
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 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 4 to 6 hours while symptoms last do not take more than 10 tablets in 24 hours, unless directed by a doctor do not take for more than 10 days unless directed by a doctor
children 6 years to under 12 years	take 1 tablet every 4 to 6 hours while symptoms last do not take more than 5 tablets in 24 hours, unless directed by a doctor do not take for more than 5 days unless directed by a doctor
children under 6 years	ask a doctor

Other information

store at room temperature in a dry place

Inactive ingredients

povidone, pregelatinzed starch, sodium starch glycolate, stearic acid

Questions?

f you have any questions or comments, or to report an adverse event, please contact 1-800-MEDLINE (633-5463)

SPL UNCLASSIFIED SECTION

www.medline.com

Manufactured in the USA with US and foreign components for:

Medline Industries, Inc., Three Lakes Drive, Northfield, IL 60093

1-800-MEDLINE

† This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol®.

PRINCIPAL DISPLAY PANEL

MEDLINE

NDC 53329-642-30

† Compare to the active Ingredient in Regular Strength Tylenol®

Regular Strength

Acetaminophen Tablets, 325 mg

+ Pain reliever

+ Fever reducer

1000 Tablets 325 mg each

INGREDIENTS AND APPEARANCE

MEDLINE ACETAMINOPHEN

acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53329-642
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)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	white	Score	2 pieces
Shape	ROUND (ound flat faced beveled edge)	Size	12mm
Flavor		Imprint Code	GPI;A325;
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53329-642-30	100 in 1 BOTTLE; Type 0: Not a Combination Product	12/26/2013	12/31/2023
2	NDC:53329-642-98	1000 in 1 BOTTLE; Type 0: Not a Combination Product	12/26/2013	12/31/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	12/26/2013	12/31/2023

Labeler - Medline Industries, LP (025460908)

Revised: 11/2021

Document Id: d1040ffc-2529-3dfa-e053-2a95a90a79e7

Set id: 46175721-4cf7-42d0-8ef0-2d51d695a49e

Version: 7

Effective Time: 20211117