TENSION HEADACHE RELIEF- acetaminophen and caffeine tablet

TENSION HEADACHE RELIEF by

Drug Labeling and Warnings

TENSION HEADACHE RELIEF by is a Otc medication manufactured, distributed, or labeled by SPIRIT PHARMACEUTICALS LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

PURPOSE

• 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

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

INGREDIENTS AND APPEARANCE

TENSION HEADACHE RELIEF 
acetaminophen and caffeine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68210-0019
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
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
Color	red	Score	no score
Shape	OVAL (CAPSULE SHAPED TABLET)	Size	18mm
Flavor		Imprint Code	S431
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68210-0019-2	1 in 1 CARTON	03/16/2018
1		24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 68210-0019-1	1 in 1 CARTON	04/06/2020
2		15 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	03/16/2018

Labeler - SPIRIT PHARMACEUTICALS LLC (179621011)