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Drug Facts
8hr Arthritis Pain Relief Tablet, Extended Release
FDA Label NDC 70000-0733
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Leader/ Cardinal Health 110, Inc. for the product 8hr Arthritis Pain Relief (NDC 70000-0733). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient (in each caplet)
Acetaminophen 650 mg
Otc - Purpose
Purpose
Pain reliever/ fever reducer
Indications & Usage
Uses
- temporarily relieves minor aches and pains due to:
- temporarily reduces fever
- minor pain of arthritis
- muscular aches n backache
- premenstrual and menstrual cramps
- the common cold n headache
- toothache
Warnings
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.
Otc - 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
Otc - Ask Doctor
Ask a doctor before use if you have liver disease
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
Otc - Stop Use
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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdosage
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.
Dosage & Administration
Directions Do not take more than directed.
See overdose warning
| adults |
|
| under 18
years of age |
|
Other Safety Information
Other information
- store between 20-25°C (68-77°F)
- The FDA approved dissolution methods differ from USP
Inactive Ingredient
Inactive ingredients carnauba wax, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin
Otc - Questions
Questions or comments? Call 1-877-290-4008
Package Label.Principal Display Panel
Apap-50s-label (Apap 50s Label)
Apap-50s-ifc (Apap 50s Ifc)
Lc-apap-label-100s (Lc Apap Label 100s)
Lc-apap-ifc-100s (Lc Apap Ifc 100s)
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