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NDC 59779-0594-50 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 in the HUMAN OTC DRUG category. It is labeled and distributed by CVS Pharmacy. The primary component is ACETAMINOPHEN; ASPIRIN; CAFFEINE.
Product Information
| NDC | 59779-0594 |
|---|---|
| Product ID | 59779-594_4aa1485d-4dc9-405d-8f19-b80274ea28f7 |
| 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 | Extra Strength |
| Non-Proprietary Name | Acetaminophen, Aspirin, Caffeine |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 250; 250; 65 |
| Active Ingredient Units | mg/1; mg/1; mg/1 |
| Substance Name | ACETAMINOPHEN; ASPIRIN; CAFFEINE |
| Labeler Name | CVS Pharmacy |
| 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 | n/a |
Package
Package Images
NDC 59779-0594-50 (59779059450)
| NDC Package Code | 59779-594-50 |
|---|---|
| Billing NDC | 59779059450 |
| Package | 1 BOTTLE, PLASTIC in 1 BOX (59779-594-50) / 50 TABLET in 1 BOTTLE, PLASTIC |
| Marketing Start Date | 2016-06-30 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL e08fd0c4-0f29-4458-b1be-3d025257dbc3 Details
Active ingredients (in each caplet)
Uses
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
- shock
- asthma (wheezing)
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.
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.
Directions
Inactive ingredients
Principal Display Panel
Compare to the active ingredients in Excedrin® Extra Strength†
Caplets
Extra Strength
Headache Relief
Acetaminophen, Aspirin (NSAID) & Caffeine
Pain Reliever / Pain Reliever Aid
CAPLETS
†This product is not manufactured or distributed by Novartis, distributor of Excedrin® Extra Strength.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
Distributed by CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
©2016 CVS/Pharmacy CVS.com®
1-800-SHOP CVS
INGREDIENTS AND APPEARANCE
| HEADACHE RELIEF
EXTRA STRENGTH
acetaminophen, aspirin, caffeine tablet |
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| Labeler - CVS Pharmacy (062312574) |