Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 0dcf54e7-de0c-426a-9b49-2ac2e8b6bdb0
Route
ORAL
Published
Effective Date 2024-10-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg)
Inactive Ingredients
Hydroxyethyl Cellulose (140 Mpa.s At 5%) Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Starch, Corn Sodium Starch Glycolate Type A Corn Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: G650 Shape: capsule Color: white Size: 19 mm Score: 1
Marketing Status
ANDA Completed Since 2020-04-30 Until 2026-04-30

Description

Acetaminophen USP,650 mg

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen USP,650 mg

Uses
  • temporarily relieves minor aches and pains due to:
    • minor pain of arthritis
    • backache
    • muscular aches
    • 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.

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
Product Label
READYinCASE Arthritis Pain Reliever
Other Information
  • store between 20-25°C (68-77°F)
Inactive Ingredients

hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid



Questions Or Comments?

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

Principal Display Panel

Compare to the active ingredient in Tylenol® 8HR Arthritis Pain

see new warning

arthritis pain reliever

acetaminophen extended-release tablets USP, 650 mg

pain reliever/fever reducer

  • for the temporary relief of minor arthritis pain
  • contains no aspirin

caplets*

(*capsule-shaped bi-layer tablets)

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

TAMPER EVIDENT: DO NOT USE IF FOIL INNER SEAL IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by:

PL Developments

200 Hicks Street

Westbury, NY 11590

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

Active Ingredient (in Each Caplet)

Acetaminophen USP,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
    • backache
    • muscular aches
    • toothache
    • premenstrual and menstrual cramps
    • headache
    • the common cold
  • 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 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.

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
Product Label
READYinCASE Arthritis Pain Reliever
Other Information (Other information)
  • store between 20-25°C (68-77°F)
Inactive Ingredients (Inactive ingredients)

hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid



Questions Or Comments? (Questions or comments?)

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

Principal Display Panel

Compare to the active ingredient in Tylenol® 8HR Arthritis Pain

see new warning

arthritis pain reliever

acetaminophen extended-release tablets USP, 650 mg

pain reliever/fever reducer

  • for the temporary relief of minor arthritis pain
  • contains no aspirin

caplets*

(*capsule-shaped bi-layer tablets)

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

TAMPER EVIDENT: DO NOT USE IF FOIL INNER SEAL IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by:

PL Developments

200 Hicks Street

Westbury, NY 11590

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

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

Acetaminophen USP,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

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