Acetaminophen by PD-Rx Pharmaceuticals, Inc. ACETAMINOPHEN tablet

Acetaminophen by

Drug Labeling and Warnings

Acetaminophen by is a Otc medication manufactured, distributed, or labeled by PD-Rx Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Acetaminophen 500mg

Purpose

Pain reliever/fever reducer

Uses

Temporarily relieves minor aches and pains due to:

• the commom cold
• headache
• backache
• minor pain of arthritis
• toothache
• muscular aches
• menstrual cramps

Temporarily reduces fever

Warnings

Liver warning:

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

• more than 8 tablets in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product
  
  Allergy warning:Acetaminophen may cause severe skin reaction. 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.
• 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).
  
• Adult and Children 12 years and over: take 2 tablets, every 4 to 6 hours while symptoms last. Do not take more than 6 tablets 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.
  

Inactive ingredients

Povidone, Pregelatinized corn starch, sodium starch glycolate, stearic acid.

Questions?

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

16 HOW SUPPLIED/STORAGE AND HANDLING

Acetaminophen tablets, 500mg, are available for oral administration as white, round, imprinted with PH044 .

Bottles of 20 (NDC: 55289-880-29)

Bottles of 24 (NDC: 55289-880-24)

Bottles of 30 (NDC: 55289-880-30)

Bottles of 100 (NDC: 55289-880-01)

Storage Store at 20°C to 25°C (68°F to 77°F)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55289-880(NDC:16103-376)
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 K30 (UNII: U725QWY32X)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	PH044
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55289-880-24	24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/12/2018
2	NDC: 55289-880-30	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/12/2018
3	NDC: 55289-880-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/12/2018
4	NDC: 55289-880-20	20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/09/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	01/12/2018

Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)

Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)

Establishment
Name	Address	ID/FEI	Business Operations
PD-Rx Pharmaceuticals, Inc.		156893695	repack(55289-880)