Timely 699r Arthritis Pain Relief- Acetaminophen Extended-release Tablets Usp, 650 Mg

Timely 699r Arthritis Pain Relief- Acetaminophen Extended-release Tablets Usp, 650 Mg
SPL v4
SPL
SPL Set ID d580b9c5-1999-4156-9bda-9bf87302fa62
Route
ORAL
Published
Effective Date 2024-06-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg)
Inactive Ingredients
Starch, Corn Povidone K30 Magnesium Stearate Hypromellose, Unspecified Triacetin Carnauba Wax Titanium Dioxide Cellulose, Microcrystalline Sodium Starch Glycolate Type A Hydroxyethyl Cellulose (140 Mpa.s At 5%)

Identifiers & Packaging

Pill Appearance
Imprint: 71 Shape: capsule Color: white Size: 19 mm Score: 1
Marketing Status
ANDA Completed Since 2021-10-04 Until 2026-04-30

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
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
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)

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 between 20-25°C (68-77°F)
  • The FDA approved Dissolution methods differ from USP

Inactive Ingredients

carnauba wax, hydroxyethylcellulose, hypromellose, povidone, pregelatinized starch, sodium starch glycolate, magnesium stearate, microcrystalline cellulose, triacetin, titanium dioxide

Under 18 Years of Age
  • ask a doctor
Questions Or Comments?

Call 1-877-290-4008

Contains No Aspirin

Principal Display Panel
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
Adults (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
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)

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 between 20-25°C (68-77°F)
  • The FDA approved Dissolution methods differ from USP

Inactive Ingredients (Inactive ingredients)

carnauba wax, hydroxyethylcellulose, hypromellose, povidone, pregelatinized starch, sodium starch glycolate, magnesium stearate, microcrystalline cellulose, triacetin, titanium dioxide

Under 18 Years of Age (under 18 years of age)
  • ask a doctor
Questions Or Comments? (Questions or comments?)

Call 1-877-290-4008

Contains No Aspirin

Principal Display Panel
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 (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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