Active Ingredient(S)
Acetaminophen 250 mg
Aspirin 250 mg (NSAID*)
Caffeine 65 mg
* nonsteroidal anti-inflammatory drug
Headache Relief Tablet, Film Coated
FDA Label NDC 85828-285
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Grocery Outlet for the product Headache Relief (NDC 85828-285). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient(s), purpose, use(s), warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Pain reliever
Pain reliever
Pain reliever aid
Use(S)
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
- asthma (wheezing)
- shock
- adult takes more than 8 tablets in 24 hours, which is the maximum daily amount
- taken with other drugs containing acetaminophen
- adult has 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
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 heart beat.
Do Not Use
- if you have ever had an allergic reaction to
acetaminophen, aspirin or 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 a history of stomach problems, such as heartburn
- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
- you are taking a diuretic
- you have asthma
Ask A Doctor Or Pharmacist Before Use If
- taking a prescription drug for diabetes, gout, or arthritis
- taking any other drug, or under a doctor’s care for any
serious condition
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
- painful area is red or swollen
- pain gets worse or lasts for more than 10 days
- ever gets worse or lasts for more than 3 days
- any new symptoms occur
These could be signs of a serious condition
If Pregnant Or Breastfeeding,
ask a health professional before use. It is especially important not to use aspirin
during the last 3 months of pregnancy unless specifically
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
(1-800-222-1222) right away. Quick medical attention is
critical for adults as well as for children even if you do not
notice the 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 tablets every 6 hours; not more than 8 tablets in 24 hours
children under 12 years: ask a doctor
Other Information
store at 20°-25°C (68°-77°F)
Inactive Ingredients
corn starch, croscarmellose sodium, crospovidone, hypromellose, microcrystalline
cellulose, polyethylene glycol, povidone, pregelatinized
starch, silicon dioxide, stearic acid, titanium dioxide
Questions/Comments
Call 1-877-290-4008
Principal Display Panel
Carton (Headache Relief 1)
Label (Headache Relief 2)
* Please review the disclaimer below.
