TENSION HEADACHE RELIEF- acetaminophen, caffeine tablet 
Pioneer Life Sciences, LLC

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Tension Headache Relief (Acetaminophen 500mg and caffeine 65mg)

Active Ingredients  (in each caplet)

Acetaminophen 500mg
Caffeine 65 mg

Purpose

Acetaminophen 500mg............................................................................................................Pain reliever
Caffeine 65mg................................................................................................................... Pain reliever aid

Uses:

temporarily relieves minor aches and pains due to:

•headache
•muscular aches

Warnings:

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.

Liver warning:This product contains acetaminophen. Severe liver damage may occur if you take

•more than 6 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 Doctor:

Ask a doctor before use if

•you have liver disease

ASK DOCTOR/PHARMACIST:

Ask a doctor or pharmacist before use if you are

•taking the blood thinning drug warfarin

Stop use and ask doctor if 

■any new symptoms occur

■painful area is red or swollen

■pain gets worse or lasts for more than 10 days

■fever gets worse or lasts for more than 3 days. These could be signs of a serious condition.

PREGNANCY

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

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

■adults and children 12 years and over: take 2 caplets every 6 hours; not more than 6 caplets in 24 hours

■chlidren 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.

INACTIVE INGREDIENTS

Colloidal Silicon Dioxide, Croscarmellose Sodium, D & C Red # 27, F D & C yellow # 6, F D & C Blue # 2, Microcrystalline Cellulose, Magnesium Stearate, Polyethylene Glycol, Polyvinyl Pyrrolidone, Pregelatinized Starch, Polyvinyl Alcohol, Stearic Acid Powder, Titanium Dioxide, Talc.

QUESTIONS OR COMMENTS?

Call 1-732-698-5070 Monday through Friday 9AM to 5PM EST.

PRINCIPAL DISPLAY PANEL

Tension Headache Relief

TENSION HEADACHE RELIEF 
acetaminophen, caffeine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72090-004
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
TALC (UNII: 7SEV7J4R1U)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Product Characteristics
ColorredScoreno score
ShapeCAPSULE (Capsule shape Tablet) Size28mm
FlavorImprint Code None
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72090-004-02200 in 1 BOTTLE; Type 0: Not a Combination Product08/03/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01308/03/2020
Labeler - Pioneer Life Sciences, LLC (014092742)

Revised: 4/2024
Document Id: 0c24ed20-9e87-4f51-9aa8-ecfc01f9e51b
Set id: ac9efd62-8fee-b777-e053-2995a90a3783
Version: 5
Effective Time: 20240422
 
Pioneer Life Sciences, LLC