TENSION HEADACHE RELIEF- acetaminophen, caffeine tablet

Tension Headache Relief by

Drug Labeling and Warnings

Tension Headache Relief by is a Otc medication manufactured, distributed, or labeled by NUVICARE LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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 OR BREAST FEEDING

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TENSION HEADACHE RELIEF 
acetaminophen, caffeine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84324-002
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	65 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	red	Score	no score
Shape	CAPSULE (Capsule shape Tablet)	Size	28mm
Flavor		Imprint Code	None
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84324-002-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	07/30/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	07/30/2024

Labeler - NUVICARE LLC (119257565)

Registrant - NUVICARE LLC (119257565)