TENSION HEADACHE RELIEF capsule

Tension Headache Relief by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredient (in each caplet)

Acetaminophen 500 mg
Caffeine 65mg

Purpose

Pain reliever
Pain reliever aid

Uses

temporary relief of minor aches and pains due to   ■ headache   ■ muscular aches

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you   ■ take more than 8 tablets in 24 hours, which is the maximum daily amount   ■ take with other drugs containing acetaminophen   ■ have 3 or more alcoholic drinks every day while using this product

Allergy alert: Aspirin may cause a severe allergic reaction which may include:   ■ hives   ■ facial swelling   ■ asthma (wheezing)   ■ shock
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, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally rapid heartbeat.

Do Not Use

 ■ with any other drug containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.

Ask doctor before use if you have

liver disease

Stop Use and ask a doctor if

■ any new symptoms occur    ■ symptoms do not get better or worsen    ■ 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

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a PoisonControlCenter immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms

Directions

Do not exceed recommended dosage.
Adults and children 12 years and over: take 2 tablets every 6 hours. Do not take more than 8 tablets in 24 hours
Children under 12 years: ask a doctor

Inactive Ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, D&C Red #27, FD&C Red #40, FD&C Yellow #6, hypromellose, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, stearic acid, titanium dioxide.

Package/Label Principal Display Panel

Health A2Z®

*Compare to the active ingredients in Excedrin® Tension Headache

See new warnings information

TENSION HEADACHE RELIEF
Acetaminophen and Caffeine
Aspirin Free
Pain Reliever/Pain Reliever Aid

Caplets

 

Tension Headache Relief 24ct. Caplets

Tension Headache Relief 24ct. Caplets

INGREDIENTS AND APPEARANCE

TENSION HEADACHE RELIEF 
tension headache relief capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69168-029
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)
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSES (UNII: 3NXW29V3WO)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	RED	Score	no score
Shape	CAPSULE	Size	17mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69168-029-24	24 in 1 BOTTLE; Type 0: Not a Combination Product	11/26/2014
2	NDC: 69168-029-98	200 in 1 BOTTLE; Type 0: Not a Combination Product	11/26/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	11/26/2014

Labeler - Allegiant Health (079501930)