MEDLINE ACETAMINOPHEN- acetaminophen tablet
Medline Industries, LP

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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640 Extra Strength Acetaminophen

Active ingredient (in each caplet)

Acetaminophen 500 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. The maximum daily dose of this product is 8 tables (4,000 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 daily amount
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.
for 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

Ask a doctor or pharmacist before use if

the user is taking the blood thinning drug warfarin.

Stop use and ask a doctor if

symptoms do not improve
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: 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

Adults and children 12 years and over	▪ take 2 caplets every 6 hours while symptoms last ▪ do not take more than 8 caplets in 24 hours unless directed by a doctor ▪ do not take 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)

Manufacturing information

www.medline.com Manufactured in the USA with US and foreign components by:

Medline Industries, Inc., Three Lakes Drive, Northfield, IL 60093 1-800-MEDLINE

RA19GMN

REF OTC22110

Package Label

53329-640-98

MEDLINE ACETAMINOPHEN
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53329-640
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, UNSPECIFIED (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	Score	no score
Shape	OVAL (Capsule Shaped Tablet)	Size	18mm
Flavor		Imprint Code	GPI;A5;
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53329-640-98	1000 in 1 BOTTLE; Type 0: Not a Combination Product	12/26/2013	11/30/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	12/26/2013	11/30/2022

Labeler - Medline Industries, LP (025460908)

Revised: 11/2021

Document Id: d0fdb66e-24db-281f-e053-2995a90a5723

Set id: fb6b9d35-15fb-42cd-937c-fa2f866f1896

Version: 8

Effective Time: 20211117

Medline Industries, LP