NDC 63941-104 Extra Strength Pain Relief
Acetaminophen Tablet, Coated Oral
Product Information
What is NDC 63941-104?
The NDC code 63941-104 is assigned by the FDA to the product Extra Strength Pain Relief which is a human over the counter drug product labeled by Valu Merchandisers Company. The generic name of Extra Strength Pain Relief is acetaminophen. The product's dosage form is tablet, coated and is administered via oral form. The product is distributed in 5 packages with assigned NDC codes 63941-104-01 1 bottle, plastic in 1 carton / 24 tablet, coated in 1 bottle, plastic, 63941-104-02 1 bottle, plastic in 1 carton / 50 tablet, coated in 1 bottle, plastic, 63941-104-04 1 bottle, plastic in 1 carton / 100 tablet, coated in 1 bottle, plastic, 63941-104-06 500 tablet, coated in 1 bottle, plastic , 63941-104-09 2 bottle, plastic in 1 carton / 100 tablet, coated in 1 bottle, plastic. 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 Extra Strength Pain Relief?
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.
Product Characteristics
Color(s) | WHITE (C48325) |
Shape | OVAL (C48345) |
Size(s) | 17 MM |
Imprint(s) | M2A4;57344 |
Score | 1 |
Product Packages
NDC Code 63941-104-01
Package Description: 1 BOTTLE, PLASTIC in 1 CARTON / 24 TABLET, COATED in 1 BOTTLE, PLASTIC
NDC Code 63941-104-02
Package Description: 1 BOTTLE, PLASTIC in 1 CARTON / 50 TABLET, COATED in 1 BOTTLE, PLASTIC
NDC Code 63941-104-04
Package Description: 1 BOTTLE, PLASTIC in 1 CARTON / 100 TABLET, COATED in 1 BOTTLE, PLASTIC
NDC Code 63941-104-06
Package Description: 500 TABLET, COATED in 1 BOTTLE, PLASTIC
NDC Code 63941-104-09
Package Description: 2 BOTTLE, PLASTIC in 1 CARTON / 100 TABLET, COATED in 1 BOTTLE, PLASTIC
Product Details
What are Extra Strength Pain Relief 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.
Extra Strength Pain Relief 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
Extra Strength Pain Relief Inactive Ingredients UNII Codes
- HYPROMELLOSES (UNII: 3NXW29V3WO)
- MINERAL OIL (UNII: T5L8T28FGP)
- POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
- POLYSORBATE 80 (UNII: 6OZP39ZG8H)
- POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
- STARCH, CORN (UNII: O8232NY3SJ)
- SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
- STEARIC ACID (UNII: 4ELV7Z65AP)
- TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
* Please review the disclaimer below.
Extra Strength Pain Relief 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
- OTHER
- ACTIVE INGREDIENT (IN EACH CAPLET)
- PURPOSE
- USES
- LIVER WARNING
- DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- OVERDOSE WARNING
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL
Other
Drug Facts
Active Ingredient (In Each Caplet)
Acetaminophen 500 mg
Purpose
Pain reliever/fever reducer
Uses
- temporarily relieves minor aches and pains due to:
- the common cold
- headache
- backache
- minor pain of arthritis
- toothache
- muscular aches
- premenstrual and menstrual cramps
- temporarily reduces fever
Liver Warning
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
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
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.
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
- do not take more than directed (see overdose warning)
- take 2 caplets every 6 hours while symptoms last
- 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
- ask a doctor
adults and children 12 years and over | |
children under 12 years |
Other Information
- store between 20-25°C (68-77°F)
- retain carton for complete product information
Inactive Ingredients
hypromellose, mineral oil, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide
Principal Display Panel
COMPARE TO THE ACTIVE INGREDIENT IN TYLENOL® EXTRA STRENGTH CAPLETS†
Best Choice®
EXTRA STRENGTH
Pain Relief
ACETAMINOPHEN
Pain Reliever/Fever Reducer
24 CAPLETS 500 mg EACH
* Please review the disclaimer below.