Acetaminophen by Global Pharm Distribution LLC ACETAMINOPHEN tablet

Acetaminophen by

Drug Labeling and Warnings

Acetaminophen by is a Otc medication manufactured, distributed, or labeled by Global Pharm Distribution LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS:

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Inactive Ingredients:

Corn Starch, Magnesium Stearate, Sodium Starch Glycolate, PVP.

USES:

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

WARNINGS:

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

• more than 4000 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 a 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 - if you are not sure whether a drug contains acetaminophen - ask a doctor or pharmacist
• for more than 10 days for pains unless directed by a doctor
• for more than 3 days for fever unless directed by a doctor
• if you have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if you have:

• liver disease.

Ask a doctor before use if 

you are taking the blood thinning drug warfarin.

Stop use and ask a doctor if

• pain gets worse or lasts more than 10 days
• ever gets worse or lasts more than 3 days
• 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. Quick medical attention is critical for adults as well as for children even if you do not noti ce 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 hours.
• do not take more than 10 days unless directed by a doctor.

Children under 12 years: ask a doctor.

OTHER INFORMATION:

Store at 20 - 25°C (68 - 77°F).

Package Labeling:

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69477-000
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
MAGNESIUM STEARATE (UNII: 70097M6I30)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69477-000-01	200 in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	11/01/2018

Labeler - Global Pharm Distribution LLC (052115351)