TENSION HEADACHE RELIEF- tension headache relief capsule 
Allegiant Health

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Drug Facts

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

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

Package/Label Principal Display Panel

Tension Headache

Tension Headache

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 
tension headache relief capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-029
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorredScoreno score
ShapeCAPSULESize17mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69168-029-2424 in 1 BOTTLE; Type 0: Not a Combination Product11/26/2014
2NDC:69168-029-98200 in 1 BOTTLE; Type 0: Not a Combination Product11/26/2014
3NDC:69168-029-2620 in 1 BOTTLE; Type 0: Not a Combination Product01/20/2020
4NDC:69168-029-371 in 1 CARTON12/15/2021
416 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:69168-029-5050 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01311/26/2014
Labeler - Allegiant Health (079501930)

Revised: 11/2017
Document Id: 5fa5b219-61a3-4b4b-bc29-a3982701ebce
Set id: b431a1a3-39c4-4d6c-afdc-c8b017ad89da
Version: 10
Effective Time: 20171116
 
Allegiant Health