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Acetaminophen Extra Strength by Family Dollar (FAMILY WELLNESS)

Medically reviewed on March 13, 2018

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg
Labeler: Family Dollar (FAMILY WELLNESS)
NDC Code: 55319-457

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.

Drug Facts

Active ingredient (in each caplet)

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

Allergy Alert  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.

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

  • more than 4000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

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 case of overdose, get medical help or contact a Poison Control Center right away. 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 caplets every 6 hours while symptoms last
    • do not take more than 6 caplets in 24 hours
    • do not take for more than 10 days unless directed by a doctor
  • children under 12 years: do not use

Other information
  • store between 20-25°C (68-77°F)

Inactive ingredients

corn starch croscamellose sodium*, hypromellose*, lactose monohydrate*, magnesium sterate*, mineral oil*, polyethylene glycol*,

polyvinyl alcohol*, povidone, purified water*, sodium starch glycolate, stearic acid*, talc*, titanium dioxide

*contains one or more of these ingredients

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENT OF TYLENOL® EXTRA STRENGTH

Extra Strength

Acetaminophen

Pain Reliever/Fever Reducer

Contains No Aspirin

CAPLETS 500 mg Each

†This product is not manufactured or distributed by McNeil Consumer Healthcare ,distributor of Tylenol® Extra Strength.

VISIT FAMILYDOLLAR.COM

DISTRIBUTED BY:

FAMILY DOLLAR SERVICES,INC.,

10401 MONROE RD.

MATTHEWS,NC28105 USA

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

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

Product Label

Family Wellness Extra Strength Acetaminophen Caplets 500mg

ACETAMINOPHEN  EXTRA STRENGTH
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-457
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
HYPROMELLOSES 
MINERAL OIL 
POVIDONES 
SODIUM STARCH GLYCOLATE TYPE A CORN 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
CROSCARMELLOSE SODIUM 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
POLYETHYLENE GLYCOLS 
POLYVINYL ALCOHOL 
WATER 
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize18mm
FlavorImprint CodeTCL341;P500
Contains    
Packaging
#Item CodePackage Description
1NDC:55319-457-501 BOTTLE, PLASTIC in 1 BOX
150 TABLET in 1 BOTTLE, PLASTIC
2NDC:55319-457-001 BOTTLE, PLASTIC in 1 BOX
2100 TABLET in 1 BOTTLE, PLASTIC
3NDC:55319-457-251 BOTTLE, PLASTIC in 1 BOX
3250 TABLET in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34301/31/2015
Labeler - Family Dollar (FAMILY WELLNESS) (024472631)

 
Family Dollar (FAMILY WELLNESS)

← See all Acetaminophen Extra Strength brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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