ACETAMINOPHEN EXTRA STRENGTH- acetaminophen capsule 
Family Dollar (FAMILY WELLNESS)

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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Drug Facts

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

 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.

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

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 gelcaps every 6 hours while symptoms last
    • do not take more than 6 gelcaps 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 at room temperature 20o- 25o C (68o- 77o F)
  • avoid high humidity

Inactive ingredients

croscarmellose sodium, D&C red #33, edible ink, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, povidone K30, pregelatinized starch, purified water, silicon dioxide, stearic acid, titanium dioxide

Questions or comments?

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

Principal Display Panel

Compare to the active ingredient of Extra Strength TYLENOL® Rapid Release Gels†

Extra Strength

Acetaminophen

Pain Reliever/Fever Reducer

Rapid Release Gelcaps

Gelcaps

500 mg each

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

Product of India

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

VISIT FAMILY DOLLAR.COM

DISTRIBUTED BY: FAMILY DOLLAR SERVICES, INC.,

10401 MONROE RD, MATTHEWS, NC 28105 USA

Product Label

Acetaminophen 500 mg

Family Wellness Extra Strength Acetaminophen

ACETAMINOPHEN  EXTRA STRENGTH
acetaminophen capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-041
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)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE K30 (UNII: U725QWY32X)  
STARCH, CORN (UNII: O8232NY3SJ)  
WATER (UNII: 059QF0KO0R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorRED, GRAY, BLUEScoreno score
ShapeCAPSULESize20mm
FlavorImprint Code G1G1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55319-041-501 in 1 CARTON07/31/201412/30/2021
150 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:55319-041-101 in 1 BOX07/31/201412/30/2021
2100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34307/31/201412/30/2021
Labeler - Family Dollar (FAMILY WELLNESS) (024472631)

Revised: 12/2019
Document Id: d86aba30-299d-4bd8-acc5-1b00da4b0893
Set id: 166cfa60-d8d6-46b2-b73d-e2765ab1a58d
Version: 2
Effective Time: 20191224
 
Family Dollar (FAMILY WELLNESS)