Arthritis Pain Relief

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (650 mg)

Inactive Ingredients

Starch, Corn Povidone K30 Magnesium Stearate Hypromellose, Unspecified Triacetin Carnauba Wax Titanium Dioxide Microcrystalline Cellulose 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 Active Since 2022-10-14

Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 650 mg

Uses

Acetaminophen Extended-Release Tablets USP, 650 mg - Arthritis Pain

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.

Acetaminophen Extended-Release Tablets USP, 650 mg - Muscle Aches and Pain

temporarily relieves minor aches and pains due to:
- muscular aches
- backache
- minor pain of arthritis
- 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 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 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	ask a doctor.

Other information

store between 20-25°C (68-77°F)
The FDA approved Dissolution methods differ from USP
do not use if carton is opened. Do not use if foil inner seal is broken or missing

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.

Inactive Ingredients

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

Questions or comments ?

Call at 1-877-376-4271 Mon-Fri 9.00am - 6.00pm EST

Principal Display Panel

NDC 25000-071-02

Acetaminophen Extended-Release Tablets USP, 650 mg - Arthritis Pain

24 count carton label

NDC 25000-071-02

Acetaminophen Extended-Release Tablets USP, 650 mg- Arthritis Pain

24 count bottle label

NDC 25000-071-08

Acetaminophen Extended-Release Tablets USP, 650 mg- Arthritis Pain

100 count carton label

NDC 25000-071-08

Acetaminophen Extended-Release Tablets USP, 650 mg- Arthritis Pain

100 count bottle label

NDC 25000-071-10

Acetaminophen Extended-Release Tablets USP, 650 mg- Arthritis Pain

225 count carton label

NDC 25000-071-10

Acetaminophen Extended-Release Tablets USP, 650 mg- Arthritis Pain

225 count bottle label

NDC 25000-071-11

Acetaminophen Extended-Release Tablets USP, 650 mg- Arthritis Pain

290 count carton label

NDC 25000-071-11

Acetaminophen Extended-Release Tablets USP, 650 mg- Arthritis Pain

290 count bottle label

NDC 25000-071-45

Acetaminophen Extended-Release Tablets USP, 650 mg- Arthritis Pain

400 count bottle label

NDC 25000-108-02

Acetaminophen Extended-Release Tablets USP, 650 mg - Muscle Aches and Pain

24 count carton label

NDC 25000-108-02

Acetaminophen Extended-Release Tablets USP, 650 mg - Muscle Aches and Pain

24 count bottle label

NDC 25000-108-08

Acetaminophen Extended-Release Tablets USP, 650 mg - Muscle Aches and Pain

100 count carton label

NDC 25000-108-08

Acetaminophen Extended-Release Tablets USP, 650 mg - Muscle Aches and Pain

100 count bottle label

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