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Tension Headache Aspirin-Free by Rite Aid

Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 500mg, CAFFEINE 65mg
Labeler: Rite Aid
NDC Code: 11822-0428

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.

Rite Aid 44-428

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 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
  • 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 (1-800-222-2222) 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 more 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 blue #2 aluminum lake, FD&C yellow #6 aluminum 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

RITE AID®
PHARMACY

*Compare to the active ingredients in Excedrin® Tension Headache

tension headache
pain reliever
acetaminophen
500 mg
caffeine 65 mg
pain reliever • pain reliever aid

aspirin free

100 COATED CAPLETS

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

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

50844    REV0113A42812

Distributed by: RITE AID
30 HUNTER LANE
CAMP HILL, PA 17011

SATISFACTION RITE AID GUARANTEE - IF YOU'RE NOT SATISFIED, WE'LL HAPPILY REFUND YOUR MONEY.

Rite Aid 44-428


TENSION HEADACHE  ASPIRIN-FREE
acetaminophen, caffeine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0428
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 
STARCH, CORN 
MAGNESIUM STEARATE 
FD&C BLUE NO. 2 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POLYVINYL ALCOHOL 
POVIDONES 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorREDScoreno score
ShapeOVALSize17mm
FlavorImprint Code44;428
Contains    
Packaging
#Item CodePackage Description
1NDC:11822-0428-21 BOTTLE, PLASTIC in 1 CARTON
1100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34301/17/2007
Labeler - Rite Aid (014578892)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(11822-0428)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(11822-0428)

Revised: 11/2015
 
Rite Aid

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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