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NDC 11673-0070-01 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 TARGET CORPORATION. The primary component is ACETAMINOPHEN; ASPIRIN; CAFFEINE.
Product Information
| NDC | 11673-0070 |
|---|---|
| Product ID | 11673-070_9cbe75fe-4586-5654-e053-2995a90a3de4 |
| 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 | TARGET CORPORATION |
| 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 11673-0070-01 (11673007001)
| NDC Package Code | 11673-070-01 |
|---|---|
| Billing NDC | 11673007001 |
| Package | 100 TABLET, COATED in 1 BOTTLE (11673-070-01) |
| Marketing Start Date | 2020-02-04 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 8e953cef-135e-f1aa-e053-2995a90aaa8b Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
REYE'S SYNDROME:
Children and teenagers who have or are recovering from chickenpox 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
Aspirin may cause a severe allergic reaction which may include:
hives
facial swelling
asthma (sneezing)
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)
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 which while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness and occasionally, rapid heartbeat.
INGREDIENTS AND APPEARANCE
| HEADACHE RELIEF
acetaminophen-aspirin-caffeine tablet, coated |
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| Labeler - TARGET CORPORATION (006961700) |
| Registrant - TIME CAP LABORATORIES, INC (037052099) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| TIME CAP LABORATORIES, INC. | 037052099 | manufacture(11673-070) | |