TENSION HEADACHE RELIEF- acetaminophen, caffeine tablet 
NUVICARE 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

•no 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 have ever had an allergic reaction 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 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.

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 (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

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 (718) 337-8733 or visit support@nuvicare.com

PL0216-01 NC-Tension Headache Relief-100ct.jpg

TENSION HEADACHE RELIEF 
acetaminophen, caffeine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84324-002
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:84324-002-01100 in 1 BOTTLE; Type 0: Not a Combination Product07/30/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01307/30/2024
Labeler - NUVICARE LLC (119257565)

Revised: 12/2025
Document Id: 407cbaec-b2d2-418c-b643-9b9bb883b2c7
Set id: ea4e50e9-2c4d-4e58-b2cb-ab23e91fd50e
Version: 3
Effective Time: 20251219
 
NUVICARE LLC