Your browser does not support JavaScript! TENSION HEADACHE RELIEF (ACETAMINOPHEN, CAFFEINE) CAPSULE [GREENBRIER INTERNATIONAL, INC.]
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TENSION HEADACHE RELIEF (acetaminophen, caffeine) capsule
[GREENBRIER INTERNATIONAL, INC.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

Active ingredients (in each caplet)

Acetaminophen 500 mg
Caffeine 65 mg

Purpose

Pain reliever
Pain reliever aid

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

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

Assured 44-428

Assured 44-428

TENSION HEADACHE RELIEF 
acetaminophen, caffeine capsule
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:33992-0428
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
CAFFEINE (CAFFEINE) CAFFEINE65 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 27 
TALC 
FD&C YELLOW NO. 6 
CROSPOVIDONE 
POLYVINYL ALCOHOL 
Product Characteristics
ColorREDScoreno score
ShapeCAPSULESize17mm
FlavorImprint Code 44;428
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:33992-0428-51 in 1 CARTON
150 in 1 BOTTLE, PLASTIC
2NDC:33992-0428-81 in 1 CARTON
224 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34301/17/2007
Labeler - GREENBRIER INTERNATIONAL, INC. (610322518)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(33992-0428)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(33992-0428)

Revised: 3/2014
 
GREENBRIER INTERNATIONAL, INC.

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