TENSION HEADACHE RELIEF- acetaminophen 500mg tablet, coated

Tension Headache Relief by

Drug Labeling and Warnings

Tension 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

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:

• Headache
• Muscular aches

Warnings

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

• more than 6 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

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 

• with any other drug containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.

Ask a doctor before use

• if you have liver disease

Ask a doctor or pharmacist

If you are taking the blood thinning drug warfarin.

Stop use and ask a doctor if

• Any new symptoms appear
• Symptoms do not get better or worsen
• 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

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

• Do not exceed recommended dosage.
• Adults and children 12 years and over: Take 2 tablets every 6 hours; do not take more than 6 tablets in 24 hours
• Children under 12 years: Ask a doctor

Other Information

• Store at controlled room temperature 20°-25°C (68°-77°F)
• TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP 

Inactive Ingredients

• Colloidal silicon doixide
• Croscarmellose sodium
• D&C red # 27
• FD&C blue # 1
• FD&C yellow # 6
• Magnesium stearate
• Microcrystalline cellulose
• Polyethylene glycol
• Pregelatinized starch
• Polyvinyl pyrolidone
• Stearic acid
• Talc
• Titanium dioxide

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

INGREDIENTS AND APPEARANCE

TENSION HEADACHE RELIEF 
acetaminophen 500mg tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71309-105
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	65 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	red	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71309-105-02	200 in 1 BOTTLE	03/01/2021
1	NDC: 71309-105-24	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)