MEDLINE ACETAMINOPHEN- acetaminophen tablet

Medline Acetaminophen by

Drug Labeling and Warnings

Medline Acetaminophen by is a Otc medication manufactured, distributed, or labeled by Medline Industries, LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Inactive Ingredients
Ingredient Name	Strength
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

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

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

Labeler - Medline Industries, Inc. (025460908)

Establishment
Name	Address	ID/FEI	Business Operations
Gemini Pharmaceuticals, Inc. dba Plus Pharma		055942270	manufacture(53329-642)