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Tension Headache Relief by Healthlife of USA

Dosage form: tablet, coated
Ingredients: ACETAMINOPHEN 500mg, CAFFEINE 65mg
Labeler: Healthlife of USA
NDC Code: 69517-118

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.

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:

  • 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 1-844-832-1138 Monday through Friday 9AM - 5PM EST or www.healthlifeofusa.com

Tension Headache Relief
Acetaminophen 500mg
Caffeine 65mg
24 CapletsCompare to Excedrin® Tension Headache active ingredients Distributed by:
Healthlife of USA LLC
Rahway
NJ 07065
www.healthlifeofusa.com

TENSION HEADACHE RELIEF 
acetaminophen 500mg tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69517-118
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
CAFFEINE (CAFFEINE) CAFFEINE65 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
D&C RED NO. 27 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 6 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
STARCH, PREGELATINIZED CORN 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
POLYETHYLENE GLYCOLS 
POVIDONE 
Product Characteristics
ColorredScoreno score
ShapeCAPSULESize18mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:69517-118-241 BOTTLE in 1 CARTON
124 TABLET, COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34305/31/2017
Labeler - Healthlife of USA (079656178)
Establishment
NameAddressID/FEIOperations
Healthlife of USA079656178repack(69517-118)
Establishment
NameAddressID/FEIOperations
Elysium Pharmaceuticals Limited915664486manufacture(69517-118), pack(69517-118)

 
Healthlife of USA

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Medically reviewed on Jun 7, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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