GENCARE HEADACHE RELIEF- acetaminophen, aspirin, caffeine tablet

GenCare Headache Relief by

Drug Labeling and Warnings

GenCare Headache Relief by is a Otc medication manufactured, distributed, or labeled by Pioneer Life Sciences, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients  (in each caplet)

Acetaminophen 250 mg

Aspirin 250 mg
Caffeine 65 mg

Purpose

Acetaminophen 250 mg............................................................Pain reliever
Aspirin 250 mg (NSAID*)..........................................................Pain reliever
Caffeine 65 mg ..................................................................Pain reliever aid
(*nonsteroidal anti-inflammatory drug)

Uses:

temporarily relieves minor aches and pains due to:

headache
a cold
arthritis
muscular aches
toothache
premenstrual & 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

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 heart beat.

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 Doctor:

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 DOCTOR/PHARMACIST:

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

STOP USE

Stop use and ask 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 for more than 10 days

■fever gets worse or lasts more than 3 days

■any new symptoms occur. These could be signs of a serious condition.

PREGNANCY

If pregnant or breast-feeding,ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in
pregnancy unless definitely 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

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 any signs or symptoms.

DIRECTIONS

■ do not use more than directed

■ drink a full glass of water with each dose

■ adults and children 12 years of age and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours
■ children under 12 years: ask a doctor

OTHER INFORMATION

■ Store between 20º-25ºC (68º-77ºF)
■ Close cap tightly after use

■ Read all product information before using.
■ Keep this box for important information.

INACTIVE INGREDIENTS

Colloidal Silicon Dioxide, Hypromellose, Microcrystalline Cellulose, Polyethylene Glycol, Pregelatinized Starch, Polyvinyl Pyrrolidone, Stearic Acid Powder, Talc.

QUESTIONS OR COMMENTS?

Call 1-732-994-2808 or email support@gencare.health

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GENCARE HEADACHE RELIEF 
acetaminophen, aspirin, caffeine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72090-007
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	65 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	250 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	250 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
STARCH, CORN (UNII: O8232NY3SJ)
POVIDONE K30 (UNII: U725QWY32X)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE	Size	27mm
Flavor		Imprint Code	S53
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72090-007-03	200 in 1 BOTTLE; Type 0: Not a Combination Product	10/02/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	10/02/2024

Labeler - Pioneer Life Sciences, LLC (014092742)