ACETAMINOPHEN- acetaminophen tablet 
Proficient Rx LP

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5427-Major

Drug Facts

Active Ingredient (in each tablet)

Acetaminophen 500 mg

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

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

Povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Questions or comments?

Call (800) 616-2471

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®

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®*

30 tablets

500mg each

71205-165-30
ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71205-165(NDC:0904-6730)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POVIDONE K30 (UNII: U725QWY32X)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUNDSize12mm
FlavorImprint Code 54;27
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71205-165-1010 in 1 BOTTLE; Type 0: Not a Combination Product12/01/2018
2NDC:71205-165-3030 in 1 BOTTLE; Type 0: Not a Combination Product12/01/2018
3NDC:71205-165-4040 in 1 BOTTLE; Type 0: Not a Combination Product12/01/2018
4NDC:71205-165-5050 in 1 BOTTLE; Type 0: Not a Combination Product12/01/2018
5NDC:71205-165-6060 in 1 BOTTLE; Type 0: Not a Combination Product12/01/2018
6NDC:71205-165-9090 in 1 BOTTLE; Type 0: Not a Combination Product12/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01309/12/2018
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIBusiness Operations
Proficient Rx LP079196022REPACK(71205-165) , RELABEL(71205-165)

Revised: 2/2024
Document Id: 0d82fe0d-89f9-4836-b270-ae755c58698e
Set id: 9af5ccc8-aac0-4339-a9f6-58fdc9b91c57
Version: 4
Effective Time: 20240201
 
Proficient Rx LP