OTC Medication Information: 8 Hour Arthritis Pain

8 HOUR ARTHRITIS PAIN- acetaminophen tablet, extended release
AMERISOURCE BERGEN

Drug Facts

Active ingredient (in each caplet)

Acetaminophen 650 mg

Purpose

Pain reliever/fever reducer

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.

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 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.

Directions

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, unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor
under 18 years of age
  • ask a doctor

Other information

  • store between 20-25°C (68-77°F)
  • retain carton for complete product information and warnings

Inactive ingredients

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

Questions or comments?

1-844-705-4384

PRINCIPAL DISPLAY PANEL

Good Neighbor Pharmacy®
Compare to Tylenol® 8HR Arthritis Pain Active Ingredient†
PUSH & TURN CAP
NDC 46122-629-71
For the Temporary Relief of Minor Arthritis Pain
8 HOUR ARTHRITIS PAIN
acetaminophen extended-release tablets, 650 mg
Pain Reliever/Fever Reducer
50 CAPLETS* 650 MG EACH
*Capsule-Shaped Bi-Layer Tablets
Actual Size

image description
(click image for full-size original)
8 HOUR ARTHRITIS PAIN
acetaminophen tablet, extended release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:46122-629
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
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)
HYPROMELLOSE 2910 (6 MPA.S)
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 400
POVIDONE K30
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A CORN
STEARIC ACID
Product Characteristics
Color white Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code G650
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46122-629-71 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 50 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC This package is contained within the CARTON (46122-629-71)
2 NDC:46122-629-78 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
2 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC This package is contained within the CARTON (46122-629-78)
3 NDC:46122-629-81 200 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
4 NDC:46122-629-62 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
4 24 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC This package is contained within the CARTON (46122-629-62)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211544 01/13/2020
Labeler — AMERISOURCE BERGEN (007914906)

Revised: 10/2023 AMERISOURCE BERGEN

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 © 2024. All Rights Reserved.