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NDC 53329-0641-98 Medline Acetaminophen 500 mg/1 Details

Medline Acetaminophen 500 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: 53329-0641-98
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen

Product Information

NDC	53329-0641
Product ID	53329-641_ec06209c-15a3-8c07-e053-2a95a90a2dbe
Associated GPIs	64200010000315
GCN Sequence Number	004490
GCN Sequence Number Description	acetaminophen TABLET 500 MG ORAL
HIC3	H3E
HIC3 Description	ANALGESIC/ANTIPYRETICS,NON-SALICYLATE
GCN	16965
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	500
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 53329-0641-98 (53329064198)

Pricing Information	N/A
NDC Package Code	53329-641-98
Billing NDC	53329064198
Package	1000 TABLET in 1 BOTTLE (53329-641-98)
Marketing Start Date	2013-12-26
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 05c06abd-bc0e-447a-ab24-5ba93e81cb59 Details

ACTIVE INGREDIENT (IN EACH CAPLET)

Acetaminophen USP, 500 mg

PURPOSE

Pain reliever/fever reducer

USES

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

WARNINGS

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 tables (3,000 mg) in 24 hours. 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.
or more than 10 days for pain unless directed by a doctor ■ for more than 3 days for fever unless directed by a doctor
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

If you are taking blood thinning drug warafin

Stop use and ask a doctor if

symptoms do not improve
or fever persists or gets worse
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. Overdose warning Taking more than the recommended dose (overdose) may cause liver damage. 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 caplets every 6 hours while symptoms last ▪ do not take more than 6 caplets in 24 hoursunless 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 at room temperature
Do not use if imprinted safety seal under cap is broken or missing

INACTIVE INGREDIENTS

Povidone, Pregelatinzed Starch, Sodium Starch Glycolate, Searic Acid.

QUESTIONS?

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MEDLINE ACETAMINOPHEN

acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53329-641
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)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	white (round flat faced beveled edge)	Score	2 pieces
Shape	ROUND	Size	12mm
Flavor		Imprint Code	GPI;A5
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53329-641-30	100 in 1 BOTTLE; Type 0: Not a Combination Product	12/26/2013	01/31/2024
2	NDC:53329-641-98	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	01/31/2024

Labeler - Medline Industries, LP (025460908)

Revised: 10/2022

Document Id: ec06209c-15a3-8c07-e053-2a95a90a2dbe

Set id: 05c06abd-bc0e-447a-ab24-5ba93e81cb59

Version: 12

Effective Time: 20221027