OTC Medication Information: Acetaminophen

ACETAMINOPHEN- acetaminophen capsule, liquid filled
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 liquid-filled capsule)

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 (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 capsules every 4 to 6 hours while symptoms last
    • do not take more than 10 capsules 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)

  • protect from heat, humidity and light

  • see end flap for expiration date and lot number

Inactive ingredients

edible white ink, FD&C red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol

Questions or comments?

1-800-426-9391

Principal display panel

CVS Health™

Compare to the active ingredient
in Tylenol® Regular Strength*

Liquid-Filled Gels

Regular Strength
Acetaminophen
325 mg, Liquid Gels

Pain reliever, Fever reducer

Aspirin free

Package Contains One Bottle

20 LIQUID-FILLED GELS

Actual Product Size and
Shape on Side Panel

*This product is not manufactured or distributed
by Johnson & Johnson Corporation, owner of the
registered trademark Tylenol® Regular Strength.
50844 ORG011971809

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2019 CVS/pharmacy
CVS.com® 1-800-SHOP CVS

Product of India V-11112

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

CVS Health 44-718
(click image for full-size original)

CVS Health 44-718

ACETAMINOPHEN acetaminophen capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-918
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
FD&C RED NO. 40
GELATIN, UNSPECIFIED
GLYCERIN
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
PROPYLENE GLYCOL
WATER
SORBITOL
Product Characteristics
Color red (clear) Score no score
Shape OVAL Size 15mm
Flavor Imprint Code 718
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69842-918-09 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC This package is contained within the CARTON (69842-918-09)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 04/15/2019 09/24/2021
Labeler — CVS PHARMACY (062312574)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 038154464 pack (69842-918)

Revised: 05/2021 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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