Active Ingredient (In Each Caplet)
Acetaminophen USP, 650 mg
Acetaminophen
FDA Label NDC 15127-332
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Select Brand for the product Acetaminophen (NDC 15127-332). 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 active ingredient (in each caplet), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Pain reliever/fever reducer
Uses
- temporarily relieves minor aches and pains due to:
- minor pain of arthritis
- muscular aches
- backache
- headache
- toothache
- the common cold
- premenstrual and menstrual cramps
- 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
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 have difficulty swallowing large tablets or capsules. People over 65 may have difficulty swallowing these tablets.
- 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 do not use for more than 10 days unless directed by a doctor |
| under 18 years of age | ask a doctor |
Other Information
- store at 20 - 25° C (68 - 77° F). Avoid excessive heat 40° C (104° F).
- see end panel for batch number and expiration date
- TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.
Inactive Ingredients
Croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, stearic acid, titanium dioxide
Questions?
Call 1-800-406-7984
Principal Display Panel
select brand®
NDC 15127-332-24
Use only as directed.
ARTHRITIS PAIN RELIEF
See New Warnings Information
Non-Aspirin
AcetaminophenCaplets*650 mg Extended-Release Tablets, USP
24 Caplets* 650 mg each (*capsule-shaped tablets)
Pain Reliever/Fever Reducer
For the Temporary Relief of Minor Arthritis Pain
Lasts up to 8 hours
٭Compare to the active ingredient of TYLENOL®ARTHRITIS PAIN
DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN
Distributed by: SELECT BRAND DISTRIBUTORS
5095101/R0412
This Is The 24 Count Blister Carton Label For Select Brand Acetaminophen Extended-release Tablets, Usp 650 mg. (Apaparthritis)
* Please review the disclaimer below.
