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Regular Strength Pain Reliever

Medically reviewed on December 18, 2017

Dosage form: tablet
Ingredients: ACETAMINOPHEN 325mg
Labeler: Healthlife of USA
NDC Code: 69517-123

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 
Regular Strength 

Drug Facts

Active Ingredient (In each tablet)

Acetaminophen 325mg

Purpose

Pain reliever/ Fever reducer

Uses

Temporarily relieves minor aches and pains due to:

  • headache
  • muscular aches
  • backache
  • minor pain of arthritis 
  • the common cold 
  • toothache
  • temporarily reduces fever 
  • premenstrual and menstrual cramps

Warnings

Liver Warning:

´╗┐This product contains acetaminophen. The maximum daily dose of this product is 9 tablets (2925 mg) in 24 hours. Severe liver damage may occur if you take:

  • more than 3000mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks everyday while using this product

Allergy alert:

´╗┐Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash 

If skin reaction occurs; stop use and seek medical help right away.

Do not use
  • with any other drug containing acetaminophen (prescription or not prescription). 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 doctor before use if you have 

liver disease

Ask your 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:

Taking more than 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 of age and over:

  • take 2 tablets every 4 to 6 hours while symptoms last
  • do not take  more than 9 tablets in 24 hours period
  • do not use for more  than 10 days unless directed by doctor

Children 6 to 12 years: take 1 tablet every 4 to 6 hours while symptoms last

  • do not use more than 5 tablets in 24 hours period
  • children under 6 years ask doctor.

Other Information
  • store at controlled room temperature 20-25°C (68-77°F)
  • read all product information before using
  • ´╗┐TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive ingredients

Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Pregelatinized Starch, Polyethylene Glycol, Polyvinyl Pyrolidone, Stearic acid, Talc, Titanium Dioxide.

Questions or comments?

Call toll free 1-844-832-1138 Monday through Friday 9AM-5PM EST or www.healthlifeofusa.com

Principal Display Panel

Regular Strength 
Pain Reliever
Acetaminophen 325mg- Pain Reliever/ Fever Reducer
30 Tablets

REGULAR STRENGTH PAIN RELIEVER 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69517-123
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE, UNSPECIFIED 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
STARCH 1500, PREGELATINIZED 
POLYETHYLENE GLYCOLS 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUNDSize10mm
FlavorImprint CodeTCL340
Contains    
Packaging
#Item CodePackage Description
1NDC:69517-123-3030 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34312/18/2017
Labeler - Healthlife of USA (079656178)
Establishment
NameAddressID/FEIOperations
Time Cap Laboratories, Inc.037052099manufacture(69517-123)

 
Healthlife of USA

← See all Regular Strength Pain Reliever brands

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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