OTC Medication Information: Acetaminophen Regular Strength

ACETAMINOPHEN REGULAR STRENGTH- acetaminophen tablet
CVS Pharmacy

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.

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. 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 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 to 6 hours while symptoms last

    • do not take more than 10 gelcaps 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 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

  • 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

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CVS
Health™

Compare to the active ingredient
in Tylenol® Regular Strength*

Rapid Release Gelcaps

Regular Strength
Acetaminophen
Gelcaps, 325 mg

Pain reliever,
Fever reducer

Aspirin Free

Actual Size

RAPID
RELEASE

365 GELCAPS

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 Tylenol® Regular Strength.
50844 ORG041767851

Distributed by:
CVS Pharmacy, Inc.
One CVS Drive
Woonsocket, RI 02895
© 2020 CVS/pharmacy
CVS.com®
1-800-SHOP CVS V-11112

CVS ® QualityMoney Back Guarantee

CVS 44-678
(click image for full-size original)

CVS 44-678

ACETAMINOPHEN REGULAR STRENGTH acetaminophen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-876
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
CROSCARMELLOSE SODIUM
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN, UNSPECIFIED
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
FERROSOFERRIC OXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
PROPYLENE GLYCOL
SHELLAC
STEARIC ACID
TITANIUM DIOXIDE
Product Characteristics
Color red, white Score no score
Shape OVAL Size 16mm
Flavor Imprint Code LB
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69842-876-51 365 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 07/24/2015
Labeler — CVS Pharmacy (062312574)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867837 manufacture (69842-876)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 038154464 pack (69842-876)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 868734088 pack (69842-876)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 967626305 pack (69842-876)

Revised: 03/2021 CVS Pharmacy

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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