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]

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
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

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