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Extra Strength Acetaminophen by Family Dollar Services Inc

Medically reviewed on July 28, 2016

Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 500mg
Labeler: Family Dollar Services Inc
NDC Code: 55319-175

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.

Pain Reliever

Active ingredients (in each tablet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

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

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 caplets (3,000 mg) in 24 hours. 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

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.

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 of breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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 4 to 6 hours while symptoms last
    • do not take more than 6 caplets 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: do not use this adult extra strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage

Other information
  • store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

Inactive ingredients

caster oil, hypromellose, povidone, sodium starch glycolate*, starch, stearic acid
*may contain this ingredient

Principal Display Panel

FAMILY wellness

COMPARE TO THE ACTIVE INGREDIENT IN EXTRA STRENGTH TYLENOL® CAPLETS†

Extra Strength
Acetaminophen
Pain Reliever/Fever Reducer
Contains No Aspirin

65 CAPLETS - 500 mg

†This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol® Caplets.
50844    REV0213A17565

DISTRIBUTED BY:
FAMILY DOLLAR SERVICES, INC.
10401 MONROE RD,
MATTHEWS NC 38105 USA

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

Family Wellness 44-175

EXTRA STRENGTH ACETAMINOPHEN 
acetaminophen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-175
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES 
POVIDONE 
STEARIC ACID 
CASTOR OIL 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize17mm
FlavorImprint Code44;175
Contains    
Packaging
#Item CodePackage Description
1NDC:55319-175-651 BOTTLE, PLASTIC in 1 CARTON
165 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
2NDC:55319-175-121 BOTTLE, PLASTIC in 1 CARTON
2100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34304/02/199307/08/2018
Labeler - Family Dollar Services Inc (024472631)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(55319-175)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(55319-175)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(55319-175)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(55319-175)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(55319-175)

 
Family Dollar Services Inc

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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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