EXTRA STRENGTH HEADACHE RELIEF- extra strength headache relief tablet, coated 
Safrel Pharmaceuticals, LLC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Extra Strength Headache Relief

Drug Facts

Purpose

Pain reliever, Pain reliever aid

Active Ingredient (in each caplet)

Acetaminophen 250mg

Aspirin 250mg

Caffeine 65mg

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 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:

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

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

Do not use

Ask a doctor before use if 

Ask a doctor or pharmacist before use if you are

Stop use and ask a doctor if

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

Other Information

Inactive ingredients

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

excedrin

EXTRA STRENGTH HEADACHE RELIEF 
extra strength headache relief tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71309-118
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScoreno score
ShapeCAPSULESize18mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71309-118-03300 in 1 BOTTLE04/01/2021
1NDC:71309-118-241 in 1 CARTON
124 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34303/01/2021
Labeler - Safrel Pharmaceuticals, LLC. (080566287)

Revised: 9/2021
Document Id: cd1ae029-289e-bdcc-e053-2995a90aeb95
Set id: c3a63704-b289-5366-e053-2a95a90a1f82
Version: 2
Effective Time: 20210928
 
Safrel Pharmaceuticals, LLC.