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Acetaminophen Extra Strength by SAVE-A-LOT FOOD STORES, LTD.

Medically reviewed on Sep 22, 2017

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg
Labeler: SAVE-A-LOT FOOD STORES, LTD.
NDC Code: 46994-175

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 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

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

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
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product
  • 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
  • redness or swelling is present
  • new symptoms occur

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.

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 caplets every 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: ask a doctor

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

Questions or comments?

1-800-426-9391

Principal Display Panel

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

Acetaminophen EXTRA STRENGTH

Acetaminophen, 500 mg

PAIN RELIEVER/FEVER REDUCER

ACTUAL
SIZE

BEING WELL®

100
CAPLETS

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

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Extra Strength Tylenol® Caplets.        50844      REV0617G17512

DISTRIBUTED BY:
SAVE-A-LOT FOOD STORES, LTD.
EARTH CITY, MO 63045
savealot.com

Save
a lot

promise
100% MONEY BACK
GUARANTEE

Being Well 44-175

ACETAMINOPHEN  EXTRA STRENGTH
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46994-175
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 
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize17mm
FlavorImprint Code44;175
Contains    
Packaging
#Item CodePackage Description
1NDC:46994-175-121 BOTTLE, PLASTIC in 1 CARTON
1100 TABLET in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34304/02/1993
Labeler - SAVE-A-LOT FOOD STORES, LTD. (095484572)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(46994-175)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837MANUFACTURE(46994-175), PACK(46994-175)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(46994-175)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(46994-175)

 
SAVE-A-LOT FOOD STORES, LTD.

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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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