Tension Headache Relief

Manufacturer: Allegiant Health
Effective date: 2017-11-16
Label type: HUMAN OTC DRUG LABEL
Version: 10
Source: full-release
Hydrated at: 2026-05-31 23:59:36

Label at a glance#

ProductTension Headache Relief

Active ingredientACETAMINOPHEN, CAFFEINE

Label structure8 sections

Indications and uses

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

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg
Caffeine 65mg

Purpose

OTC - PURPOSE SECTION

Pain reliever
Pain reliever aid

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

■ 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

OTC - ASK DOCTOR SECTION

liver disease

Stop Use and ask a doctor if

OTC - STOP USE SECTION

■ 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tension HeadacheHealth 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
410226	acetaminophen 500 MG / caffeine 65 MG Oral Capsule	PSN	10
410226	acetaminophen 500 MG / caffeine 65 MG Oral Capsule	SCD	10
410226	APAP 500 MG / Caffeine 65 MG Oral Capsule	SY	10

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
CAFFEINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7dea7767-9f52-b60a-5435-33cb9cc28bae	Product name	4	20250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4	Product name	7	20250116
0ca83774-3f79-b837-5d6f-c210102f3bc8	Product name	6	20250114
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
2dc76302-91c0-4c35-ad78-99adfb049c4b	Product name	1	20200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2b	Product name	2	20180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6	Product name	2	20161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550	Product name	2	20151105
332e86c3-7875-ca6e-f934-2206d2b31996	Product name	1	20140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21	Product name	1	20140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092	Product name	1	20140508
96c2be53-8e44-452d-56a2-d255b2f1af2d	Product name	1	20140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44	Product name	1	20140508
d223c173-c39b-d764-47d4-d671d3088815	Product name	1	20140508
e01133ad-4dcd-c7f3-454b-2ff569ee160a	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69168-029-24	Tension Headache Relief	24 in 1 BOTTLE	CAPSULE	24	10
69168-029-26	Tension Headache Relief	20 in 1 BOTTLE	CAPSULE	20	10
69168-029-37	Tension Headache Relief	1 in 1 CARTON	CAPSULE	1	10
69168-029-37	Tension Headache Relief	16 in 1 BOTTLE	CAPSULE	16	10
69168-029-50	Tension Headache Relief	50 in 1 BOTTLE	CAPSULE	50	10
69168-029-98	Tension Headache Relief	200 in 1 BOTTLE	CAPSULE	200	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69168-029	TENSION HEADACHE RELIEF CAPSULE [ALLEGIANT HEALTH]	10	Current NDC, Legacy NDC, 6 package rows	20231109_b431a1a3-39c4-4d6c-afdc-c8b017ad89da.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	1
CAFFEINE	ACTIVE INGREDIENT	3G6A5W338E	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	1
CAFFEINE	ACTIVE MOIETY	3G6A5W338E	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	1
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

Tension Headache Relief
ACETAMINOPHEN
CAFFEINE
SILICON DIOXIDE
STARCH, CORN
CROSCARMELLOSE SODIUM
D&C RED NO. 27
FD&C RED NO. 40
FD&C YELLOW NO. 6
HYPROMELLOSES
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
STEARIC ACID
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69168-029	69168-029-24, 69168-029-98, 69168-029-26, 69168-029-37, 69168-029-50

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ACETAMINOPHEN	362O9ITL9D	ACTIB
CAFFEINE	3G6A5W338E	ACTIB
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
STARCH, CORN	O8232NY3SJ	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
D&C RED NO. 27	2LRS185U6K	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
STEARIC ACID	4ELV7Z65AP	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 78 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	CAPSULE / ORAL		7 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	CAPSULE / ORAL		257 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CAPSULE / ORAL		1488 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CAPSULE / ORAL		90 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE / ORAL		72 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE / ORAL		5785 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
D&C RED NO. 27	D&C RED NO. 27	2LRS185U6K	TABLET, CHEWABLE / ORAL		7 mg	Exact identifier — unii+route 24 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CAPSULE / ORAL		1488 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	CAPSULE / ORAL		257 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
D&C RED NO. 27	D&C RED NO. 27	2LRS185U6K	TABLET, EXTENDED RELEASE / ORAL	1.43 mg		Exact identifier — unii+route 24 equally ranked IID candidates
D&C RED NO. 27	D&C RED NO. 27	2LRS185U6K	TABLET, CHEWABLE / ORAL		7 mg	Exact identifier — unii+route 24 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE / ORAL		72 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
D&C RED NO. 27	D&C RED NO. 27	2LRS185U6K	TABLET / ORAL		1 mg	Exact identifier — unii+route 24 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	CAPSULE / ORAL		257 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	CAPSULE / ORAL		2169 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	CAPSULE / ORAL		7 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CAPSULE / ORAL		1488 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE / ORAL		5785 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE / ORAL		300 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE / ORAL		72 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
D&C RED NO. 27	D&C RED NO. 27	2LRS185U6K	TABLET, EXTENDED RELEASE / ORAL	1.43 mg		Exact identifier — unii+route 24 equally ranked IID candidates
D&C RED NO. 27	D&C RED NO. 27	2LRS185U6K	TABLET / ORAL		1 mg	Exact identifier — unii+route 24 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	CAPSULE / ORAL		2169 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CAPSULE / ORAL		90 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
D&C RED NO. 27	D&C RED NO. 27	2LRS185U6K	POWDER, FOR SUSPENSION / ORAL	1.67 mg/5ml		Exact identifier — unii+route 24 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CAPSULE / ORAL		90 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
D&C RED NO. 27	D&C RED NO. 27	2LRS185U6K	POWDER, FOR SUSPENSION / ORAL	1.67 mg/5ml		Exact identifier — unii+route 24 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	CAPSULE / ORAL		7 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE / ORAL		300 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
D&C RED NO. 27	D&C RED NO. 27	2LRS185U6K	POWDER, FOR SUSPENSION / ORAL	1.67 mg/5ml		Exact identifier — unii+route 24 equally ranked IID candidates
D&C RED NO. 27	D&C RED NO. 27	2LRS185U6K	TABLET, CHEWABLE / ORAL		7 mg	Exact identifier — unii+route 24 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE / ORAL		16 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE / ORAL		300 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CAPSULE / ORAL		90 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
D&C RED NO. 27	D&C RED NO. 27	2LRS185U6K	TABLET, CHEWABLE / ORAL		7 mg	Exact identifier — unii+route 24 equally ranked IID candidates
D&C RED NO. 27	D&C RED NO. 27	2LRS185U6K	TABLET / ORAL		1 mg	Exact identifier — unii+route 24 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE / ORAL		5785 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE / ORAL		5785 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
D&C RED NO. 27	D&C RED NO. 27	2LRS185U6K	TABLET, CHEWABLE / ORAL		7 mg	Exact identifier — unii+route 24 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE / ORAL		5785 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE / ORAL		300 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	CAPSULE / ORAL		257 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
D&C RED NO. 27	D&C RED NO. 27	2LRS185U6K	TABLET, EXTENDED RELEASE / ORAL	1.43 mg		Exact identifier — unii+route 24 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE / ORAL		16 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE / ORAL		5785 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE / ORAL		16 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE / ORAL		300 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
D&C RED NO. 27	D&C RED NO. 27	2LRS185U6K	TABLET / ORAL		1 mg	Exact identifier — unii+route 24 equally ranked IID candidates
D&C RED NO. 27	D&C RED NO. 27	2LRS185U6K	POWDER, FOR SUSPENSION / ORAL	1.67 mg/5ml		Exact identifier — unii+route 24 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	CAPSULE / ORAL		257 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
D&C RED NO. 27	D&C RED NO. 27	2LRS185U6K	POWDER, FOR SUSPENSION / ORAL	1.67 mg/5ml		Exact identifier — unii+route 24 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE / ORAL		72 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
D&C RED NO. 27	D&C RED NO. 27	2LRS185U6K	TABLET, EXTENDED RELEASE / ORAL	1.43 mg		Exact identifier — unii+route 24 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	CAPSULE / ORAL		257 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE / ORAL		300 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
D&C RED NO. 27	D&C RED NO. 27	2LRS185U6K	TABLET / ORAL		1 mg	Exact identifier — unii+route 24 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	CAPSULE / ORAL		2169 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	CAPSULE / ORAL		7 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	CAPSULE / ORAL		2169 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
D&C RED NO. 27	D&C RED NO. 27	2LRS185U6K	TABLET, EXTENDED RELEASE / ORAL	1.43 mg		Exact identifier — unii+route 24 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tension Headache Relief	TENSION HEADACHE RELIEF	Allegiant Health	b431a1a3-39c4-4d6c-afdc-c8b017ad89da	2017-11-16	Warnings	Exact identifier ndc (package): 69168-029-37 ndc (package): 69168-029-98 ndc (package): 69168-029-50 ndc (package): 69168-029-24 ndc (package): 69168-029-26 ndc (product): 69168-029 ndc11 (package): 69168002998 ndc11 (package): 69168002950 ndc11 (package): 69168002924 ndc11 (package): 69168002926 ndc11 (package): 69168002937 spl id: 5fa5b219-61a3-4b4b-bc29-a3982701ebce spl set id: b431a1a3-39c4-4d6c-afdc-c8b017ad89da

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.