DrugCite

ASPIRIN-FREE TENSION HEADACHE - acetaminophen and caffeine capsule 
Rite Aid

Rite Aid 44-428

Active ingredients (in each caplet)

Acetaminophen 500 mg
(formulated with 65 mg caffeine)

Purpose

Pain reliever 

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

  • 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 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 controlled room temperature 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

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

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

50844    ORG081042812

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

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

Rite Aid 44-428

Rite Aid 44-428


ASPIRIN-FREE TENSION HEADACHE 
acetaminophen, caffeine  capsule
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 11822-0428
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
CAFFEINE (CAFFEINE) CAFFEINE 65 mg
Inactive Ingredients
Ingredient Name Strength
D&C RED NO. 27  
TALC  
FD&C YELLOW NO. 6  
Product Characteristics
Color RED Score no score
Shape CAPSULE Size 17mm
Flavor Imprint Code 44;428
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 11822-0428-2 1 BOTTLE In 1 CARTON contains a BOTTLE, PLASTIC
1 100 CAPSULE In 1 BOTTLE, PLASTIC This package is contained within the CARTON (11822-0428-2)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part343 01/17/2007

Labeler - Rite Aid (014578892)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 038154464 PACK
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867894 MANUFACTURE
Revised: 10/2012Rite Aid