Cvs Pharmacy, Inc. 8 Hr Arthritis Pain Drug Facts

Cvs Pharmacy, Inc. 8 Hr Arthritis Pain Drug Facts
SPL v2
SPL
SPL Set ID 68e5b8a7-17ca-4a29-9f0c-7350fcf65928
Route
ORAL
Published
Effective Date 2025-09-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg)
Inactive Ingredients
Carnauba Wax Silicon Dioxide Croscarmellose Sodium Hypromellose, Unspecified Magnesium Stearate Maltodextrin Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polysorbate 80 Povidone, Unspecified Stearic Acid Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: L544 Shape: oval Color: white Size: 19 mm Score: 1
Marketing Status
ANDA Active Since 2025-09-29
Description

Acetaminophen 650 mg

Purpose

Pain reliever/fever reducer

Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 650 mg

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

Directions
  • •
    do not take more than directed (see overdose warning)

adults
  • •
    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

under 18 years of age
  • •
    ask a doctor
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
Other Information
  • •
    store at 20-25°C (68-77°F)
  • •
    meets the requirements of USP Dissolution Test 4
Inactive Ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, stearic acid, titanium dioxide

Questions Or Comments?

1-800-719-9260

Principal Display Panel

CVS™

actual size

8 HR ARTHRITIS PAIN

Acetaminophen

Extended-Release Tablets USP, 650 mg

Pain Reliever, Fever Reducer

Compare to Tylenol® 8 HR Arthritis Pain active ingredient

For the Temporary Relief of Minor Arthritis Pain

225 CAPLETS, *650 mg EACH

*Capsule-Shaped Tablets

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 right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredient (in Each Caplet)

Acetaminophen 650 mg

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

Structured Label Content

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

Pain reliever/fever reducer

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 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.

Directions
  • •
    do not take more than directed (see overdose warning)

adults
  • •
    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

under 18 years of age
  • •
    ask a doctor
Do Not Use (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
Other Information (Other information)
  • •
    store at 20-25°C (68-77°F)
  • •
    meets the requirements of USP Dissolution Test 4
Inactive Ingredients (Inactive ingredients)

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, stearic acid, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-800-719-9260

Principal Display Panel

CVS™

actual size

8 HR ARTHRITIS PAIN

Acetaminophen

Extended-Release Tablets USP, 650 mg

Pain Reliever, Fever Reducer

Compare to Tylenol® 8 HR Arthritis Pain active ingredient

For the Temporary Relief of Minor Arthritis Pain

225 CAPLETS, *650 mg EACH

*Capsule-Shaped Tablets

Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Acetaminophen 650 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

liver disease

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking the blood thinning drug warfarin

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:09.288567 · Updated: 2026-03-14T23:10:23.192014