TENSION HEADACHE RELIEF- acetaminophen 500mg 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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Tension Headache Relief

Drug Facts

Tension Headache Relief

Purpose

Pain reliever, Pain reliever aid

Active Ingredients (in each caplet)

Acetaminophen   500mg

Caffeine   65mg

Uses

Temporarily relief minor aches and pains due to:

Warnings

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

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 heartbeat.

Do not Use 

Ask a doctor before use

Ask a doctor or pharmacist

If you are taking the blood thinning drug warfarin.

Stop use and ask a doctor if

If pregnant or breast-feeding

Ask a health professional before use.

Keep out of reach of children.

In case of overdosage, 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

Tension Headache Relief

Acetaminophen 500mg

Caffeine 65mg

Compare to Excedrin® Tension Headache active ingredients Distributed by:

Safrel Pharmaceuticals, LLC
Bridgewater, NJ 08807

www.safrle.com

TH

TENSION HEADACHE RELIEF 
acetaminophen 500mg tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71309-105
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
Product Characteristics
ColorredScoreno score
ShapeCAPSULESize18mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71309-105-02200 in 1 BOTTLE03/01/2021
1NDC:71309-105-241 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: 5/2021
Document Id: c3a57a57-0b57-80ca-e053-2a95a90a4eac
Set id: c3a57a57-0b56-80ca-e053-2a95a90a4eac
Version: 1
Effective Time: 20210531
 
Safrel Pharmaceuticals, LLC.