TENSION HEADACHE RELIEF- acetaminophen and caffeine tablet 
SPIRIT PHARMACEUTICALS LLC

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ASSURED TENSION HEADACHE RELIEF

Drug Facts

Active ingredients (in each caplet)Purposes
 Acetaminophen 500 mg Pain reliever
 Caffeine 65 mg Pain reliever aid

Uses

  • temporarily relieves minor aches and pains due to:
  • headache
  • muscular aches

Warnings

Liver Warning: This product contains acataminophen. Severe liver damage may occure if you take.

  • more than 6 caplets in 24 hours, whihc is the maximum daily amount.
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions.

Symptoms may include: 

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

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, 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

  • any new symptoms occur
  • painful area is red or swollen
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts for 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

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. 1-800-222-1222

Directions

  • do not use more than directed
  • adults and children 12 years and over; take 2 caplets every 6 hours; not more than 6 caplets in 24 hours
  • children under 12 years: ask a doctor

Other information

  • store at 20°-25°C (68°-77°F)
  • close cap tightly after use
  • read all product information before using. Keep this box for important information.

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, D&C Red#27, FD&C Blue#2, FD&C Yellow#6, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, purified water, stearic acid, talc, titanium dioxide

Questions or comments?

1-888-333-9792

PRINCIPAL DISPLAY PANEL

ASSURED™

COMPARE TO ACTIVE INGREDIENTS OF EXCEDRIN® TENSION HEADACHE*

Tension Headache Relief

• Acetaminophen & Caffeine
Pain Reliever/ Pain reliever aid

Actual Size

24 caplets

DO NOT USE IF CARTON IS OPENED AND/OR 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®.

ITEM# 125703

DISTRIBUTED BY GREENBRIER INTERNATIONAL, INC.
500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

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TENSION HEADACHE RELIEF 
acetaminophen and caffeine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-0019
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
POVIDONE K30 (UNII: U725QWY32X)  
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
WATER (UNII: 059QF0KO0R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorredScoreno score
ShapeOVAL (CAPSULE SHAPED TABLET) Size18mm
FlavorImprint Code S431
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68210-0019-21 in 1 CARTON03/16/201801/12/2022
124 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:68210-0019-11 in 1 CARTON04/06/202001/12/2022
215 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01303/16/201812/08/2023
Labeler - SPIRIT PHARMACEUTICALS LLC (179621011)

Revised: 12/2023
 
SPIRIT PHARMACEUTICALS LLC