EXTRA STRENGTH HEADACHE RELIEF tablet, coated

Extra Strength Headache Relief by

Drug Labeling and Warnings

Extra Strength Headache Relief by is a Otc medication manufactured, distributed, or labeled by Safrel Pharmaceuticals, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Purpose

Pain reliever, Pain reliever aid

Active Ingredient (in each caplet)

Acetaminophen 250mg

Aspirin 250mg

Caffeine 65mg

Uses

• Temporarily relieves minor aches and pains due to:
• headache
• a cold
• arthritis
• muscular aches
• sinusitis 
• 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 behaviour 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
• shock
• facial swelling
• asthma (wheezing)

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: 

• more than 8 Tablets 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, food, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.

Do not use

• if you 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 wheather 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 have asthma
• you are taking a diuretic

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 a doctor if

• you experience any of the following signs of stomach bleeding
• feel faint
• have bloody or black stools
• vomit blood
• have stomach pain that does not get better
• an allergic reaction occurs. Seek medical help right away.
• any new symptoms appear
• 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

If pregnant or breast-feeding,

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.

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 and over
• Take 2 tablets every 6 hours
• Do not take more than 8 tablets in 24 hours
• Children under 12 years: ask a doctor

Other Information

• Store at 25°C (77°F) excursions permitted between 15-30°C (59-86°F)
• TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive ingredients

• Corn starch
• Crospovidone
• Hypromellose
• Microcrystalline cellulose
• Povidone
• Propylene glycol
• Sodium Lauryl sulfate
• Sodium starch glycolate
• Stearic acid
• Titanium dioxide

Questions or comments?

Call toll free 1-844-384-3723 Monday through Friday 9AM- 5PM EST or www.safrel.com

Extra Strength Headache Relief Acetaminophen 250mg / Pain Reliever Aspirin 250mg (Nsaid) / Pain Reliever Caffeine 65mg / Pain Reliever Aid Compare to Excedrin® Extra Strength active ingredients

Distributed by:

Safrel Pharmaceuticals, LLC

Bridgewater, NJ 08807

www.safrel.com

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH HEADACHE RELIEF 
extra strength headache relief tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71309-118
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
CROSPOVIDONE (UNII: 2S7830E561)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71309-118-03	300 in 1 BOTTLE	04/01/2021
1	NDC: 71309-118-24	1 in 1 CARTON
1		24 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	03/01/2021

Labeler - Safrel Pharmaceuticals, LLC. (080566287)