NDC 0363-9538 Acetaminophen
What is NDC 0363-9538?
The NDC code 0363-9538 is assigned by the FDA to the product Acetaminophen which is a human over the counter drug product labeled by Walgreens. The product's dosage form is tablet and is administered via oral form. The product is distributed in a single package with assigned NDC code 0363-9538-25 225 tablet in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.
What are the uses for Acetaminophen?
This drug is used to treat mild to moderate pain (from headaches, menstrual periods, toothaches, backaches, osteoarthritis, or cold/flu aches and pains) and to reduce fever.
|Color(s)||RED (C48326) |
|Shape||ROUND (C48348) |
|Size(s)||11 MM |
NDC Code 0363-9538-25
Package Description: 225 TABLET in 1 BOTTLE
What are Acetaminophen Active Ingredients?
- ACETAMINOPHEN 500 mg/1 - Analgesic antipyretic derivative of acetanilide. It has weak anti-inflammatory properties and is used as a common analgesic, but may cause liver, blood cell, and kidney damage.
Acetaminophen Active Ingredients UNII Codes
- ACETAMINOPHEN (UNII: 362O9ITL9D)
- ACETAMINOPHEN (UNII: 362O9ITL9D) (Active Moiety)
NDC to RxNorm Crosswalk
- RxCUI: 198440 - acetaminophen 500 MG Oral Tablet
- RxCUI: 198440 - APAP 500 MG Oral Tablet
Acetaminophen Inactive Ingredients UNII Codes
- LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
- POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
- POVIDONE K30 (UNII: U725QWY32X)
- FD&C RED NO. 40 (UNII: WZB9127XOA)
- STEARIC ACID (UNII: 4ELV7Z65AP)
- SUCRALOSE (UNII: 96K6UQ3ZD4)
- POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
- TALC (UNII: 7SEV7J4R1U)
- TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
- STARCH, CORN (UNII: O8232NY3SJ)
- FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
* Please review the disclaimer below.
Acetaminophen Product Label
FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Product Label Table of Contents
- ACTIVE INGREDIENT (IN EACH COATED TABLET)
- LIVER WARNING:
- ALLERGY ALERT:
- 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
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF THE REACH OF CHILDREN.
- OVERDOSE WARNING:
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Active Ingredient (In Each Coated Tablet)
Acetaminophen USP, 500 mg
Pain reliever/fever reducer
■ temporarily relieves minor aches and pains due to:
■ the common cold
■ minor pain of arthritis
■ muscular aches
■ premenstrual and menstrual cramps
■ temporarily reduces fever
This product contains acetaminophen. Severe liver damage may occur if you take
■ more than 4,000 mg of acetaminophen in 24 hours
■ with other drugs containing acetaminophen
■ 3 or more alcoholic drinks every day while using this product
acetaminophen may cause severe skin reactions. Symptoms may include:
■ skin reddening
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
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 The Reach Of Children.
Keep out of the reach of children.
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.
■ do not take more than directed (see overdose warning)
adults and children 12 years and over
■ take 2 tablets every 6 hours while symptoms last
■ do not take more than 6 tablets in 24 hours, unless directed by a doctor
■ do not take more than 10 days unless directed by a doctor
children under 12 years
■ ask a doctor
■ store at 20°-25°C (68°-77°F). See USP Controlled Room Temperature
■ do not use if imprinted safety seal under cap is broken or missing
FD&C red no. 40, FD&C yellow no. 6, lecithin, polyethylene glycol, povidone k-30, polyvinyl alcohol, pregelatinized starch, stearic acid, sucralose, talc, titanium dioxide.
Questions Or Comments?
call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST.
* Please review the disclaimer below.