ACETAMINOPHEN- acetaminophen 325mg tablet

Acetaminophen by

Drug Labeling and Warnings

Acetaminophen by is a Otc medication manufactured, distributed, or labeled by America's Pharmacy Source LLC, Pharbest Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Acetaminophen 325mg

Purpose

Pain reliever/fever reducer

Uses

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

Warnings

Liver warning:This product contains acetaminophen. The maximum daily dose of this prduct is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children. Severe liver damage may occur if

• adult takes more than 4000 mg of acetaminophen in 24 hours, which is the maximum daily amount
• child takes more than 5 doses in 24 hours, which is the maximum daily amount
• 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 you have

liver disease.

Ask a doctor or pharmacist 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 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 the case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

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 to 11 years:
    • take 1 tablet, every 4 to 6 hours while symptoms last
    • do not take more than 5 tablets in 24 hours
    • do not use for more than 5 days unless directed by a doctor
  • children under 6 years: ask a doctor

Other information

• store between 20-25°C (68-77°F)

Inactive ingredients

povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Questions?

Adverse drug event call: (866) 562-2756 (Mon - Fri 8 AM to 4 PM EST)

PRINCIPAL DISPLAY PANEL

COMPARE TO ACTIVE

INGREDIENT IN

TYLENOL ® REGULAR STRENGTH

AMERICA'S

PHARMACY SOURCE

REGULAR STRENGTH

Acetaminophen

Pharbetol l Pain Reliever l Fever Reducer

NDC# 72615-0001-0

100 TABLETS - 325mg Each

www.AmericasPharmacySource.com

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen 325mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72615-0001
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)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	PH020
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72615-0001-0	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/02/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	10/02/2019

Labeler - America's Pharmacy Source LLC (116701866)

Registrant - America's Pharmacy Source LLC (116701866)

Establishment
Name	Address	ID/FEI	Business Operations
Pharbest Pharmaceuticals, Inc.		557054835	manufacture(72615-0001) , analysis(72615-0001) , repack(72615-0001) , relabel(72615-0001)