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Pain Reliever by Family Dollar (FAMILY WELLNESS)

Medically reviewed on Jan 10, 2018

Dosage form: tablet
Ingredients: ACETAMINOPHEN 325mg
Labeler: Family Dollar (FAMILY WELLNESS)
NDC Code: 55319-491

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 tablet)

Acetaminophen 325 mg

Purpose

Pain reliever/ fever reducer

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

Warnings

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

  • adult takes more than 4000 mg of acetaminophen in 24 hours
  • child takes more than 5 doses in 24 hours, which is the maximum daily amount
  • taken with other drugs containing acetaminophen
  • adult has 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
  • 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 the user has

liver disease.

Ask a doctor or pharmacist before use if the user is

taking the blood thinning drug warfarin.

Stop use and ask a doctor if
  • pain gets worse or lasts more than 10 days in adults
  • pain gets worse or lasts more than 5 days in children under 12 years
  • 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 Contorl 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 tablets every 4 to 6 hours while symptoms last
  • do not take more than 10 tablets in 24 hours
  • do not use for more than 10 days unless directed by a doctor
children 6-11 years
  • take 1 tablet every 4 to 6 hours while symptoms last
  • do not take more than 5 tablets in 24 hours
  • do not use for more than 5 days unless directed by a doctor
children under 6 years
  •  ask a doctor

Other information
  • store between 20-25ºC (68-77ºF)

Inactive ingredients

povidone, pregelatinized starch, sodium starch glycolate*, stearic acid

*may contain this ingredient

Questions or comments?

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

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENT IN TYLENOL® REGULAR STRENGTH†

REGULAR STRENGTH

Pain Reliever

Acetaminophen 325 mg

Pain Reliever/ Fever Reducer

For ages 6 years and over

Tablets

**This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Tylenol® Regular Strtength.

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY: MIDWOOD BRANDS, LLC

10611 MONROE RD., MATTHEWS, NC 28105

Product Label

FAMILY WELLNESS Acetaminophen Pain Reliever Fever Reducer

PAIN RELIEVER 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-491
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE 
STARCH, CORN 
SODIUM STARCH GLYCOLATE TYPE A CORN 
STEARIC ACID 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize10mm
FlavorImprint CodeTCL340
Contains    
Packaging
#Item CodePackage Description
1NDC:55319-491-241 BOTTLE, PLASTIC in 1 BOX
124 TABLET in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34312/31/2017
Labeler - Family Dollar (FAMILY WELLNESS) (024472631)

 
Family Dollar (FAMILY WELLNESS)

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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