ACETAMINOPHEN EXTRA STRENGTH- acetaminophen tablet, coated 
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 44-531C-Delisted

Active ingredient (in each tablet)

Acetaminophen 500 mg 

Purpose

Pain reliever/fever reducer 

Uses

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

  • blisters
  • rash
  • skin reddening

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.

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 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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number 

Inactive ingredients

corn starch, D&C red #27 aluminum lake, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate*, stearic acid, sucralose, talc, titanium dioxide

*may contain this ingredient

Questions or comments?

 1-800-426-9391

Principal Display Panel

FAMILY
wellness™

COMPARE TO THE ACTIVE INGREDIENT OF EXTRA STRENGTH TYLENOL®†

EXTRA STRENGTH
Acetaminophen
Pain Reliever/Fever Reducer

Contains No Aspirin

Easy To Swallow Sweet Coated Tablets

50 TABLETS
500 mg each

100% SATISFACTION GUARANTEED
OR YOUR MONEY BACK

ACTUAL SIZE

OTC
network

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

50844   REV1018A53115

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 

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

44-531

44-531

ACETAMINOPHEN  EXTRA STRENGTH
acetaminophen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-531
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)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
POVIDONE (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize11mm
FlavorImprint Code 44;531
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55319-531-151 in 1 CARTON12/11/200512/09/2023
150 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34312/11/200512/09/2023
Labeler - Family Dollar Services Inc (024472631)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(55319-531)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(55319-531)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837MANUFACTURE(55319-531)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088PACK(55319-531)

Revised: 1/2020
Document Id: 88ad7e60-6d84-477e-b95e-e43a30061d7d
Set id: 6f2d2129-da03-4293-a1e5-9d1e38140501
Version: 10
Effective Time: 20200123
 
Family Dollar Services Inc