ACETAMINOPHEN EXTRA STRENGTH- acetaminophen tablet 
Family Dollar Services Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Family Wellness 44-519-delisted

Active ingredient (in each gelcap)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

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

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.

Do not use

  • if you are allergic to acetaminophen or any of the inactive ingredients in this product
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

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.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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
  • adults and children 12 years and over
    • take 2 gelcaps every 6 hours while symptoms last
    • do not take more than 6 gelcaps 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 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • avoid high humidity
  • see end flap for expiration date and lot number

Inactive ingredients

croscarmellose sodium, D&C red #33, FD&C blue #1, FD&C red #40, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

FAMILY
wellness™

COMPARE TO THE ACTIVE INGREDIENT OF
EXTRA STRENGTH TYLENOL® RAPID RELEASE GELS*

EXTRA STRENGTH
Acetaminophen
Pain Reliever/Fever Reducer

Contains No Aspirin

50 RAPID RELEASE
GELCAPS • 500 mg each

ACTUAL SIZE

100% SATISFACTION
GUARANTEED
OR YOUR MONEY BACK

OTC
network

TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

DISTRIBUTED BY:
MIDWOOD BRANDS, LLC

10611 MONROE RD,
MATTHEWS, NC 28105

50844           REV0417E51915

NOT 100% SATISFIED?
Return package and unused product
within 30 days to any Family Dollar store
for a refund (with receipt) or exchange.

*This product is not manufactured or
distributed by Johnson & Johnson
Corporation, owner of the registered
trademark Extra Strength Tylenol® Rapid
Release Gels.

Family Wellness 44-519

Family Wellness 44-519

ACETAMINOPHEN  EXTRA STRENGTH
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-519
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
SHELLAC (UNII: 46N107B71O)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorBLUE, REDScoreno score
ShapeOVALSize19mm
FlavorImprint Code L;5
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55319-519-151 in 1 CARTON05/10/200408/14/2020
150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34305/10/200408/14/2020
Labeler - Family Dollar Services Inc (024472631)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(55319-519)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(55319-519)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837MANUFACTURE(55319-519) , PACK(55319-519)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088PACK(55319-519)

Revised: 7/2020
 
Family Dollar Services Inc