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Extra Strength Headache Relief

Medically reviewed on August 28, 2017

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg
Labeler: ALDI INC.
NDC Code: 64024-175

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. Severe liver damage may occur if you take:

  • more than 8 caplets in 24 hours, which is the maximum daily amount
  • 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 damamge. 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 4 to 6 hours while symptoms last
    • do not take more than 8 caplets in 24 hours
    • 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 controlled room temperature 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

PRODUCT PACKAGING

Welby®

HEALTH

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

Extra Strength

Headache Relief

acetaminophen

Aspirin Free

Pain Reliever and Fever Reducer

See New Warnings Information

500mg each

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

50844     REV0709A17512

Quality, performance and satisfaction are always DOUBLE guaranteed at ALDI®.  If for any reason, you are not 100% satisfied with this product, we will gladly replace the product AND refund your money.  When corresponding, please include code information from box.

Distributed by ALDI Inc. Batavia, IL 60510-1477

Product Packaging

EXTRA STRENGTH HEADACHE RELIEF 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64024-175
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES 
POVIDONES 
STEARIC ACID 
CASTOR OIL 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize18mm
FlavorImprint Code44;175
Contains    
Packaging
#Item CodePackage Description
1NDC:64024-175-121 BOTTLE, PLASTIC in 1 CARTON
1100 TABLET in 1 BOTTLE, PLASTIC
2NDC:64024-175-151 BOTTLE, PLASTIC in 1 CARTON
250 TABLET in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34304/02/199308/28/2018
Labeler - ALDI INC. (944259522)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(64024-175)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(64024-175)

 
ALDI 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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