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 TIME CAP LABS INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each caplet)

Acetaminophen 500 mg

Caffeine 65 mg

PURPOSE

Purposes

Pain reliever

Pain reliever aid

INDICATIONS & USAGE

Uses

Temporarily relieves minor aches and pains due to:

• headache
• muscular aches

WARNINGS

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 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 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 right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION

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

STORAGE AND HANDLING

Other information

• store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
• use by expiration date on package

INACTIVE INGREDIENT

Inactive ingredients carnauba wax, colloidal silicon dioxide, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol (PEG) 400, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, talc, titanium dioxide

QUESTIONS

Questions or comments? Call 1-877-290-4008

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TENSION HEADACHE RELIEF 
acetaminophen, caffeine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49483-373
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
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
POVIDONE (UNII: FZ989GH94E)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
STARCH, CORN (UNII: O8232NY3SJ)
CARNAUBA WAX (UNII: R12CBM0EIZ)
TALC (UNII: 7SEV7J4R1U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	red	Score	no score
Shape	CAPSULE (Capsule shaped tablet)	Size	18mm
Flavor		Imprint Code	TCL373
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49483-373-20	200 in 1 BOTTLE; Type 0: Not a Combination Product	08/08/2023
2	NDC: 49483-373-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	06/16/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	06/16/2021

Labeler - TIME CAP LABS INC (037052099)

Registrant - TIME CAP LABS INC (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
TIME CAP LABS INC		037052099	manufacture(49483-373)