TENSION HEADACHE RELIEF capsule, coated

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(s)

Acetaminophen 500 mg
Caffeine 65mg

Purpose

Pain reliever
Pain reliever aid

Use(s)

temporarily relieves 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

• if you are allergic to acetaminophen
• with any other drug containing acetaminophen (prescription or non-prescription). 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.

Pregnancy/Breastfeeding

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.

Directions

Do not use more than directed

Adults and children 12 years and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours

Children under 12 years: ask a doctor

Other information

• Store at 20-25°C (68-77° F) 

• Do not use if imprinted safety seal under cap is broken or missing
  

Inactive ingredients

corn starch, croscarmellose sodium, crospovidone, D&C red #27 aluminum lake, FD&C red #40
aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone,
pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide

Questions

1-888-952-0050 (Monday through Friday 9AM - 5PM EST

Principal Display Panel

Tension Headache

Tension Headache

INGREDIENTS AND APPEARANCE

TENSION HEADACHE RELIEF 
tension headache relief capsule, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69168-001
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
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CROSPOVIDONE (UNII: 2S7830E561)
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	red	Score	no score
Shape	CAPSULE	Size	17mm
Flavor		Imprint Code	AZ029
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69168-001-24	1 in 1 CARTON	11/22/2021
1		24 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	11/22/2021

Labeler - Allegiant Health (079501930)