Tension Headache Relief description, usages, side effects, indications, overdosage, supplying and lots more!

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Tension Headache Relief

Greenbrier International, Inc.

Assured 44-428


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each caplet)

Acetaminophen 500 mg
Caffeine 65 mg

Purpose

Pain reliever
Pain reliever aid

Tension Headache Relief Uses

  • temporarily relieves 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 8 caplets in 24 hours, which is the maxiumum 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

  • if you are allergic to acetaminophen
  • with any other drug containing acetaminophen (prescription or nonprescription).  If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. 

Ask a doctor before use if you have

liver disease.

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

Stop use and ask a doctor if

  • new symptoms appear
  • symptoms do not get better or worsen
  • painful area is red and swollen
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days

These could be signs of a serious condition. 

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage.  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
    (see overdose warning)
  • adults and children12 years and over: take 2 caplets every 6 hours.  Do not take mroe than 8 caplets in 24 hours.
  • children under 12 years: do not use this product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Tension Headache Relief Other information

  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number 

Inactive ingredients

corn starch, crospovidone, D&C red #27 aluminum lake, FD&C #2 aluminum lake, FD&C #6 aluminium lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate, stearic acid, talc, titanium dioxide 

Questions or comments?

 1-800-426-9391

Principal display panel

Assured™

NDC 33992-428-08

COMPARE TO ACTIVE INGREDIENTS IN EXCEDRIN® Tension Headache*

TENSION HEADACHE RELIEF
• Acetaminophen
and Caffeine
Pain Reliever / Pain Reliever Aid

50 CAPLETS

*This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Excedrin® Tension Headache.
50844    ORG011342815

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Tension Headache Relief
Assured 44-428

Tension Headache Relief

Acetaminophen, Caffeine CAPSULE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:33992-0428
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 500 mg
CAFFEINE 65 mg

Inactive Ingredients

Ingredient Name Strength
D&C RED NO. 27
talc
FD&C YELLOW NO. 6
CROSPOVIDONE
POLYVINYL ALCOHOL

Product Characteristics

Color Size Imprint Code Shape
RED 17 mm 44;428 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 50 in 1 BOTTLE, PLASTIC
2 24 in 1 BOTTLE, PLASTIC
3 NDC:33992-0428-8 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2007-01-17


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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