Pain Relief

Manufacturer: H E B | LNK International, Inc.
Effective date: 2026-01-27
Label type: HUMAN OTC DRUG LABEL
Version: 18
Source: full-release
Hydrated at: 2026-06-01 01:35:03

Label at a glance#

ProductPain Relief Extra Strength

Active ingredientACETAMINOPHEN

Label structure9 sections

Indications and uses

temporarily relieves minor aches and pains due to: headache the common cold muscular aches backache minor pain from arthritis toothache premenstrual and menstrual cramps temporarily reduces fever

Dosage and administration

do not take more than directed adults and children 12 years and over take 2 gelcaps every 6 hours while symptoms last do not take more than 6 gelcaps in 24 hours, unless directed by a doctor do not take for more than 10 days unless directed by a doctor children under 12 years: ask a doctor

Storage and handling

use by expiration date on package store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F) avoid high humidity

Contacts and useful links#

PhoneLabel contact1-800-426-9391

Label contents#

Full prescribing information#

Active ingredient (in each gelcap)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor aches and pains due to:
- headache
- the common cold
- muscular aches
- backache
- minor pain from arthritis
- toothache
- premenstrual and menstrual cramps
temporarily reduces fever

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

more than 4,000 mg of acetaminophen in 24 hours
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.

Do not use

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

liver disease.

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin.

Stop use and ask a doctor if

OTC - STOP USE SECTION

pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
redness or swelling is present
any new symptoms appear

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 overdose, get medical help or contact a Poison Control Center right away. 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 take more than directed
adults and children 12 years and over
- take 2 gelcaps every 6 hours while symptoms last
- do not take more than 6 gelcaps in 24 hours, unless directed by a doctor
- do not take for more than 10 days unless directed by a doctor
children under 12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

use by expiration date on package
store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
avoid high humidity

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, D&C red #33, FD&C blue #1, FD&C red #40, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Tylenol^® Extra Strength Rapid
Release Gels active ingredient*

NDC 37808-195-20

H-E-B_®

TEXAS-SIZE PACK
225 CT

Extra Strength
Pain Relief
Acetaminophen, 500 mg
Pain Reliever/Fever Reducer

225 GELCAPS

actual
size

TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

H•E•B_®
100%
GUARANTEE
promise
If you aren't completely pleased
with this product, we'll be happy to
replace it or refund your money.
You have our word on it.

*This product is not manufactured or
distributed by Kenvue Inc., owner of the
registered trademark Tylenol^® Extra Strength
Rapid Release Gels.

50844 REV0525D51920 49903-2510

MADE WITH PRIDE AND CARE FOR
H-E-B^®, SAN ANTONIO, TX 78204

HEB 44-519

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
198440	acetaminophen 500 MG Oral Tablet	PSN	18
198440	acetaminophen 500 MG Oral Tablet	SCD	18
198440	APAP 500 MG Oral Tablet	SY	18

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0041220359882	GTIN-13: 0041220359882 EAN-13: 0041220359882 GTIN-12: 041220359882 UPC-A: 041220359882 GTIN storage (14 digits): 00041220359882	heb-44-519-1.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
37808-195-08	Pain ReliefExtra Strength	24 in 1 BOTTLE, PLASTIC	TABLET, COATED	24	18
37808-195-08	Pain ReliefExtra Strength	1 in 1 CARTON	TABLET, COATED	1	18
37808-195-12	Pain ReliefExtra Strength	1 in 1 CARTON	TABLET, COATED	1	18
37808-195-12	Pain ReliefExtra Strength	100 in 1 BOTTLE, PLASTIC	TABLET, COATED	100	18
37808-195-20	Pain ReliefExtra Strength	225 in 1 BOTTLE, PLASTIC	TABLET, COATED	225	18

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	4
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	4
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	4
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	4
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	4
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	4
GELATIN	INACTIVE INGREDIENT	2G86QN327L	4
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	4
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	4
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	4
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	4

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

Pain Relief Extra Strength
Acetaminophen
CROSCARMELLOSE SODIUM
D&C RED NO. 33
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN, UNSPECIFIED
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
FERROSOFERRIC OXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
STARCH, CORN
PROPYLENE GLYCOL
SHELLAC
STEARIC ACID
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
37808-195	37808-195-08, 37808-195-12, 37808-195-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ACETAMINOPHEN	362O9ITL9D	ACTIB
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
D&C RED NO. 33	9DBA0SBB0L	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
GELATIN, UNSPECIFIED	2G86QN327L	IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED	9XZ8H6N6OH	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
FERROSOFERRIC OXIDE	XM0M87F357	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
POVIDONE, UNSPECIFIED	FZ989GH94E	IACT
STARCH, CORN	O8232NY3SJ	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SHELLAC	46N107B71O	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 1 · 56 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, COATED / ORAL		224 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, COATED / ORAL		58 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, COATED / ORAL		1 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	TABLET, COATED / ORAL	NA		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE H)	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	TABLET, COATED / ORAL	13.6 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET, COATED / ORAL	1 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, COATED / ORAL	0.52 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, COATED / ORAL	42.12 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, COATED / ORAL		16 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, COATED / ORAL	0.1 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE H)	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	TABLET, COATED / ORAL	13.6 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET, COATED / ORAL	NA		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET, COATED / ORAL	NA		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, COATED / ORAL	42.4 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	TABLET, COATED / ORAL	49.2 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, COATED / ORAL		49 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, COATED / ORAL		16 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, COATED / ORAL		58 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, COATED / ORAL	42.4 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET, COATED / ORAL	1 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, COATED / ORAL		1 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET, COATED / ORAL	NA		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, COATED / ORAL	0.52 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, COATED / ORAL		16 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, COATED / ORAL		49 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, COATED / ORAL		224 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, COATED / ORAL		16 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, COATED / ORAL		224 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, COATED / ORAL	0.1 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, COATED / ORAL		1 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, COATED / ORAL		224 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, COATED / ORAL	42.12 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	TABLET, COATED / ORAL	49.2 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	TABLET, COATED / ORAL	49.2 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, COATED / ORAL		58 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, COATED / ORAL	42.12 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, COATED / ORAL	0.1 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE H)	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	TABLET, COATED / ORAL	13.6 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	TABLET, COATED / ORAL	NA		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	TABLET, COATED / ORAL	49.2 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, COATED / ORAL	42.4 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, COATED / ORAL	0.1 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET, COATED / ORAL	NA		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, COATED / ORAL	0.52 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, COATED / ORAL	42.4 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, COATED / ORAL	42.12 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE H)	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	TABLET, COATED / ORAL	13.6 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, COATED / ORAL		58 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	TABLET, COATED / ORAL	NA		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET, COATED / ORAL	1 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, COATED / ORAL	0.52 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, COATED / ORAL		1 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, COATED / ORAL		49 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, COATED / ORAL		49 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	TABLET, COATED / ORAL	NA		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET, COATED / ORAL	1 mg		Exact identifier — unii+route+dosage form 4 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
Pain Relief Extra Strength	ACETAMINOPHEN	H E B	99699cd6-ba7d-4db0-9f0f-0f2c1a369138	2026-01-27	Warnings	Exact identifier ndc (package): 37808-195-12 ndc (package): 37808-195-08 ndc (package): 37808-195-20 ndc (product): 37808-195 ndc11 (package): 37808019512 ndc11 (package): 37808019508 ndc11 (package): 37808019520 spl id: eef88a02-d62d-47e1-85f1-16d3d20e86d1 spl set id: 99699cd6-ba7d-4db0-9f0f-0f2c1a369138

Reported adverse events (FAERS/openFDA)#

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