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Pain Relief Regular Strength by CVS Pharmacy

Medically reviewed on September 19, 2017

Dosage form: tablet
Ingredients: ACETAMINOPHEN 325mg
Labeler: CVS Pharmacy
NDC Code: 69842-678

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.

CVS 44-678

Active ingredient (in each gelcap)

 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 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 10 gelcaps (3,250 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
  • 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.

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 gelcaps every 4-6 hours while symptoms last
    • do not take more than 10 gelcaps in 24 hours, unless directed by a doctor
    • do not take 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 15º-30ºC (59º-86ºF)
  • avoid high humidity
  • use by expiration date on package

Inactive ingredients

corn starch, croscarmellose sodium, FD&C red #40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, povidone, propylene glycol, shellac glaze, stearic acid, titanium dioxide

Questions or comments?

 1-800-426-9391

Principal display panel

CVS Health™

Compare to the active ingredient in Tylenol® Regular Strength*

Rapid Release Gelcaps

NDC 69842-678-51

Regular Strength
Pain Relief
ACETAMINOPHEN,
325 mg
Pain reliever,
Fever reducer

Contains no aspirin 

Actual Size

365 GELCAPS

RAPID RELEASE

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

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

50844    ORG051567851

Distributed by:
CVS Pharmacy, Inc.

One CVS Drive
Woonsocket, RI 02895
© 2016 CVS/pharmacy
CVS.com®
1-800-SHOP CVS V-11112

CVS 44-678

PAIN RELIEF  REGULAR STRENGTH
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-678
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
CROSCARMELLOSE SODIUM 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
GELATIN 
HYPROMELLOSES 
POLYETHYLENE GLYCOLS 
POVIDONE 
PROPYLENE GLYCOL 
STEARIC ACID 
TITANIUM DIOXIDE 
FERROSOFERRIC OXIDE 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
Product Characteristics
ColorRED, WHITEScoreno score
ShapeOVALSize16mm
FlavorImprint CodeLB
Contains    
Packaging
#Item CodePackage Description
1NDC:69842-678-51365 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34307/24/2015
Labeler - CVS Pharmacy (062312574)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(69842-678)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837MANUFACTURE(69842-678)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(69842-678)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(69842-678)

 
CVS Pharmacy

← See all Pain Relief Regular Strength brands

Further information

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

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