Acetaminophen by Proficient Rx LP ACETAMINOPHEN tablet

Acetaminophen by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

Active Ingredient (in each tablet)

Acetaminophen 500 mg

PURPOSE

Purpose

Pain reliever/ Fever reducer

Uses

Temporarily reduces fever and relieves minor aches and pains due to:

• headache 
• muscular aches 
• backache 
• minor pain of arthritis 
• common cold 
• toothache 
• premenstrual and
• menstrual cramps

WARNINGS

Liver warning: This product contains acetaminophen. 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.

• 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 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 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

Other Information

store at room temperature

INACTIVE INGREDIENT

Povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Questions or comments?

Call (800) 616-2471

SPL UNCLASSIFIED SECTION

SAVE CARTON FOR COMPLETE DRUG FACTS

Do not use if carton is open or if imprinted safety seal under cap is broken or missing.

Distributed By:

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152

Repackaged By:

Proficient Rx LP

Thousand Oaks, CA 91320

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol®

PRINCIPAL DISPLAY PANEL

See New Warnings Information and Directions

Acetaminophen Extra Strength Tablets

Aspirin Free

Strong Pain and Fever Relief

Compare to active ingredient in Extra Strength Tylenol®*

50 tablets

500mg each

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71205-165(NDC:0904-6730)
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
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
POVIDONE K30 (UNII: U725QWY32X)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	white	Score	2 pieces
Shape	ROUND	Size	12mm
Flavor		Imprint Code	54;27
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71205-165-10	10 in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2018
2	NDC: 71205-165-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2018
3	NDC: 71205-165-40	40 in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2018
4	NDC: 71205-165-50	50 in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2018
5	NDC: 71205-165-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2018
6	NDC: 71205-165-90	90 in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	09/12/2018

Labeler - Proficient Rx LP (079196022)

Establishment
Name	Address	ID/FEI	Business Operations
Proficient Rx LP		079196022	REPACK(71205-165) , RELABEL(71205-165)