NDC 0363-0865 Headache Relief Extra Strength
Acetaminophen, Aspirin, Caffeine Tablet Oral
Product Information
What is NDC 0363-0865?
The NDC code 0363-0865 is assigned by the FDA to the product Headache Relief Extra Strength which is a human over the counter drug product labeled by Walgreens. The generic name of Headache Relief Extra Strength is acetaminophen, aspirin, caffeine. 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 0363-0865-25 250 tablet 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 Headache Relief Extra Strength?
This product is used as Pain relieverPain relieverPain reliever aid. Temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches toothache premenstrual and menstrual cramps
Product Characteristics
Color(s) | WHITE (C48325) |
Shape | CAPSULE (C48336) |
Size(s) | 17 MM |
Imprint(s) | TCL370 |
Score | 1 |
Product Details
What are Headache Relief Extra Strength Active Ingredients?
- ACETAMINOPHEN 250 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.
- ASPIRIN 250 mg/1 - The prototypical analgesic used in the treatment of mild to moderate pain. It has anti-inflammatory and antipyretic properties and acts as an inhibitor of cyclooxygenase which results in the inhibition of the biosynthesis of prostaglandins. Aspirin also inhibits platelet aggregation and is used in the prevention of arterial and venous thrombosis. (From Martindale, The Extra Pharmacopoeia, 30th ed, p5)
- CAFFEINE 65 mg/1 - A methylxanthine naturally occurring in some beverages and also used as a pharmacological agent. Caffeine's most notable pharmacological effect is as a central nervous system stimulant, increasing alertness and producing agitation. It also relaxes SMOOTH MUSCLE, stimulates CARDIAC MUSCLE, stimulates DIURESIS, and appears to be useful in the treatment of some types of headache. Several cellular actions of caffeine have been observed, but it is not entirely clear how each contributes to its pharmacological profile. Among the most important are inhibition of cyclic nucleotide PHOSPHODIESTERASES, antagonism of ADENOSINE RECEPTORS, and modulation of intracellular calcium handling.
Headache Relief Extra Strength Active Ingredients UNII Codes
- ACETAMINOPHEN (UNII: 362O9ITL9D)
- ACETAMINOPHEN (UNII: 362O9ITL9D) (Active Moiety)
- ASPIRIN (UNII: R16CO5Y76E)
- ASPIRIN (UNII: R16CO5Y76E) (Active Moiety)
- CAFFEINE (UNII: 3G6A5W338E)
- CAFFEINE (UNII: 3G6A5W338E) (Active Moiety)
NDC to RxNorm Crosswalk
- RxCUI: 308297 - acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet
- RxCUI: 308297 - APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral Tablet
Headache Relief Extra Strength Inactive Ingredients UNII Codes
- CARNAUBA WAX (UNII: R12CBM0EIZ)
- SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
- STARCH, CORN (UNII: O8232NY3SJ)
- HYPROMELLOSES (UNII: 3NXW29V3WO)
- CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
- MINERAL OIL (UNII: T5L8T28FGP)
- POVIDONE (UNII: FZ989GH94E)
- SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
- STEARIC ACID (UNII: 4ELV7Z65AP)
- TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
Pharmacologic Class(es)
- Anti-Inflammatory Agents, Non-Steroidal - [CS]
- Central Nervous System Stimulant - [EPC] (Established Pharmacologic Class)
- Central Nervous System Stimulation - [PE] (Physiologic Effect)
- Cyclooxygenase Inhibitors - [MoA] (Mechanism of Action)
- Decreased Platelet Aggregation - [PE] (Physiologic Effect)
- Decreased Prostaglandin Production - [PE] (Physiologic Effect)
- Methylxanthine - [EPC] (Established Pharmacologic Class)
- Nonsteroidal Anti-inflammatory Drug - [EPC] (Established Pharmacologic Class)
- Platelet Aggregation Inhibitor - [EPC] (Established Pharmacologic Class)
- Xanthines - [CS]
* Please review the disclaimer below.
Headache Relief Extra Strength 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 INGREDIENTS (IN EACH CAPLET)
- PURPOSES
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- STOP USE AND ASK DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
- PACKAGE LABEL
Active Ingredients (In Each Caplet)
Acetaminophen 250 mg
Aspirin 250 mg (NSAID)*
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
Purposes
Pain reliever
Pain reliever
Pain reliever aid
Uses
- temporarily relieves minor aches and pains due to:
- headache
- a cold
- arthritis
- muscular aches
- toothache
- premenstrual and menstrual cramps
Warnings
Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
- hives
- facial swelling
- shock
- asthma (wheezing)
- more than 8 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
- are age 60 or older
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- have 3 or more alcoholic drinks every day while using this product
- take more or for a longer time than directed
If a skin reaction occurs, stop use and seek medical help right away.
Allergy alert: Aspirin may cause a severe allergic reaction, which may include:
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.
Do Not Use
- if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Ask A Doctor Before Use If
- you have liver disease
- stomach bleeding warning applies to you
- you have asthma
- you are taking a diuretic
- you have a history of stomach problems, such as heartburn
- you have high blood pressure, heart disease, liver cirrhosis. or kidney disease
Ask A Doctor Or Pharmacist Before Use If You Are
- taking a prescription drug for diabetes, gout, or arthritis
- taking any other drug, or are under a doctor’s care for any serious condition
Stop Use And Ask Doctor If
- an allergic reaction occurs, Seek medical help right away
- any new symptoms appear.
- you experience any of the following signs of stomach bleeding
- feel faint
- vomit blood
- have bloody or black stools
- have stomach pain that does not get better
- ringing in the ears or loss of hearing occurs
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts for more than 3 days
- painful area is red or swollen
these could be signs of a serious condition.
If Pregnant Or Breast-Feeding,
ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away. 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 use more than directed
- drink a full glass of water with each dose
- adults and children 12 years and over: take 2 caplets every 6 hours; do not take more than 8 caplets in 24 hours
- children under 12 years: ask a doctor
Other Information
- store between 20°-25°C (68°-77°F)
Inactive Ingredients
carnauba wax, colloidal silicon dioxide, corn starch, hypromellose, microcrystalline cellulose, mineral oil, povidone, sodium starch glycolate, stearic acid, titanium dioxide
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Compare to the active ingredients in Excedrin® Extra Strength††
Headache Relief
ACETAMINOPHEN / ASPIRIN (NSAID)
PAIN RELIEVER / CAFFEINE / PAIN RELIEVER AID
EXTRA STRENGTH
CAPLETS
††This product is not manufactured or distributed by GSK Consumer Healthcare distributor of Excedrin® Extra Strength.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
DISTRIBUTED BY: WALGREENS CO., 200 WILMOT RD., DEERFIELD, IL 60015
Package Label
WALGREENS Headache Relief
* Please review the disclaimer below.