OTC Medication Information: Acetaminophen Extended Release

ACETAMINOPHEN EXTENDED RELEASE- acetaminophen tablet
CVS Pharmacy

Active ingredient (in each caplet)

Acetaminophen 650 mg

Purpose

Pain reliever/fever reducer

Uses

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

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 6 caplets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks ever 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 a 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.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1800-222-1222) 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 and over
    • take 2 caplets every 8 hours with water
    • swallow whole; do not crush, chew, split or dissolve
    • do not take more than 6 caplets in 24 hours
    • do not use for more than 10 days unless directed by a doctor
  • children under 12 years of age: ask a doctor

Other information

  • store between 20-25°C (68-77°F)

Inactive ingredients

D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hydroxyethyl cellulose, magnesium stearate, maize starch, microcrystalline cellulose povidone, pregelatinized starch, sodium lauryl sulfate

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

†Compare to the active ingredient of Tylenol® 8HR Muscle Aches & Pain

Extended-release

Pain Reliever

Acetaminophen 650 mg

Pain reliever/Fever reducer

For up to 8 hours relief of minor muscle aches & pain

Caplets*

(*capsule-shaped bi-layer tablets)

†This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Tylenol® 8 HR Muscle Aches & Pain.

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by: CVS Pharmacy Inc

one CVS Drive, Woonsocket RI 02895

Product Label

Acetaminophen 650 mg
(click image for full-size original)

CVS HEALTH 8HR Arthritis Pain Relief

ACETAMINOPHEN EXTENDED RELEASE
acetaminophen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-093
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 650 mg
Inactive Ingredients
Ingredient Name Strength
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)
MAGNESIUM STEARATE
STARCH, CORN
MICROCRYSTALLINE CELLULOSE
POVIDONE
SODIUM LAURYL SULFATE
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code 511
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69842-093-10 1 BOTTLE, PLASTIC in 1 BOX contains a BOTTLE, PLASTIC
1 100 TABLET in 1 BOTTLE, PLASTIC This package is contained within the BOX (69842-093-10)
2 NDC:69842-093-24 1 BOTTLE, PLASTIC in 1 BOX contains a BOTTLE, PLASTIC
2 24 TABLET in 1 BOTTLE, PLASTIC This package is contained within the BOX (69842-093-24)
3 NDC:69842-093-15 1 BOTTLE, PLASTIC in 1 BOX contains a BOTTLE, PLASTIC
3 150 TABLET in 1 BOTTLE, PLASTIC This package is contained within the BOX (69842-093-15)
4 NDC:69842-093-01 100 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207035 04/01/2020
Labeler — CVS Pharmacy (062312574)

Revised: 12/2020 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.

Terms of Use | Copyright © 2021. All Rights Reserved.