Search by Drug Name or NDC
NDC 00363-0770-42 HEADACHE RELIEF 250; 250; 65 mg/1; mg/1; mg/1 Details
HEADACHE RELIEF 250; 250; 65 mg/1; mg/1; mg/1
HEADACHE RELIEF is a ORAL TABLET, COATED in the HUMAN OTC DRUG category. It is labeled and distributed by WALGREENS. The primary component is ACETAMINOPHEN; ASPIRIN; CAFFEINE.
Product Information
NDC | 00363-0770 |
---|---|
Product ID | 0363-0770_e3acc0ae-b992-671b-e053-2995a90a2d07 |
Associated GPIs | |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | HEADACHE RELIEF |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | ACETAMINOPHEN, ASPIRIN, CAFFEINE |
Product Type | HUMAN OTC DRUG |
Dosage Form | TABLET, COATED |
Route | ORAL |
Active Ingredient Strength | 250; 250; 65 |
Active Ingredient Units | mg/1; mg/1; mg/1 |
Substance Name | ACETAMINOPHEN; ASPIRIN; CAFFEINE |
Labeler Name | WALGREENS |
Pharmaceutical Class | Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [E |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH NOT FINAL |
Application Number | part343 |
Listing Certified Through | 2024-12-31 |
Package
Package Images




NDC 00363-0770-42 (00363077042)
NDC Package Code | 0363-0770-42 |
---|---|
Billing NDC | 00363077042 |
Package | 1 BOTTLE in 1 CARTON (0363-0770-42) / 24 TABLET, COATED in 1 BOTTLE |
Marketing Start Date | 2021-08-30 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL b5a45daa-05b1-4d6d-e053-2995a90a8444 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
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
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:
- hives
- facial swelling
- asthma (wheezing)
- shock
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- 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
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is
higher if you:
- 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
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.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Stop use and ask a doctor if
an allergic reaction occurs. Seek medical help right away.
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
painfull area is red or swollen
pain gets worse or lasts for more than 10 days
fever gets worse or lasts for more than 3 days
any new symptoms occur
These could be signs of a serious condition
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
OTHER INFORMATION
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
HEADACHE RELIEF
acetaminophen, aspirin, caffeine tablet, coated |
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
Labeler - WALGREENS (008965063) |
Registrant - TIME CAP LABORATORIES, INC. (037052099) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
TIME CAP LABORATORIES, INC. | 037052099 | manufacture(0363-0770) |