Drug Facts
DRUG FACTS
The following Structured Product Label (SPL) was submitted to the FDA by Walgreens for the product Walgreens Headache Relief Extra Strength (NDC 0363-6693). 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 drug facts, active ingredient (in each softgel), purpose, uses, warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if you are taking, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
DRUG FACTS
Acetaminophen 250 mg
Aspirin 250 mg (NSAID)*
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
Pain reliever
Pain reliever
Pain reliever aid
Temporarily relieves minor aches and pains due to:
■ headache ■ a cold ■ arthritis ■ muscular aches
■ toothache ■ premenstrual and menstrual cramps
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 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 geltabs 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 occasional rapid heartbeat.
■ 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
■ 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 you are taking
■ a prescription drug for diabetes, gout, or arthritis
■ any other drug, or are under a doctor's care for any serious
condition
■ 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
■ fever gets worse or lasts for more than 3 days
■ any new symptoms occur
These could be signs of a serious condition.
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.
Overdose warning: In case of overdose, get medical help or
contact a Poison Control Center right away. Prompt medical
attention is critical for adults as well as children even if you do
not notice any signs or symptoms.
■ do not use more than directed (see overdose warning)
■ drink a full glass of water with each dose
■ adults and children 12 years and over: take 2 geltabs every
6 hours; not more than 8 geltabs in 24 hours
■ children under 12 years: ask a doctor
■ store at room temperature between 20-25°C (68-77°F)
■ avoid excessive heat, cold and humidity
corn starch, D&C yellow #10 aluminum lake, edible black ink, ethyl
cellulose, FD&C blue #1 aluminum lake, FD&C red #40 aluminum
lake, gelatin, glycerin, hypromellose, isopropyl alcohol, lactose
monohydrate, light mineral oil, microcrystalline cellulose, pregelatinized
potato starch, purified water, pvpk-30, sorbitol sorbitan solution,
stearic acid, talc, titanium dioxide, triacetin
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