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pain relief

Better Living Brands LLC Pain Relief Drug Facts

Approved
Approval ID

0e0a73f9-8c18-41fd-812e-8be20287e77a

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 26, 2025

Manufacturers
FDA

Safeway

DUNS: 009137209

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Acetaminophen

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code21130-719
Application NumberM013
Product Classification
M
Marketing Category
C200263
G
Generic Name
Acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateAugust 26, 2025
FDA Product Classification

INGREDIENTS (8)

ACETAMINOPHENActive
Quantity: 500 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 3/24/2025

Principal Display Panel

COMPARE TO Extra Strength Tylenol® Caplets active ingredient

Signature SELECT™

PAIN RELIEF

EXTRA STRENGTH

LOVE IT OR IT’S ON US

ACETAMINOPHEN CAPLETS 500 mg

PAIN RELIEVER/FEVER REDUCER

• For Adults

• Aspirin Free

Actual Size

250 CAPLETS

![signature-select-pain-relief-carton- image.jpg](/dailymed/image.cfm?name=signature-select-pain-relief-carton- image.jpg&id=894887)

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 1/3/2024

Uses

temporarily relieves minor aches and pains due to:

the common cold

headache

backache

minor pain of arthritis

toothache

muscular aches

premenstrual and menstrual cramps

temporarily reduces fever

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 1/3/2024

Active ingredient (in each caplet)

Acetaminophen 500 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 1/3/2024

Purpose

Pain reliever/fever reducer

WARNINGS SECTION

LOINC: 34071-1Updated: 1/3/2024

Warnings

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

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

if you have ever had an allergic reaction to this product or any of its ingredients

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

pain gets worse or lasts more than 10 days

fever gets worse or lasts more than 3 days

new symptoms occur

redness or swelling is present

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 3/24/2025

Directions

**do not take more than directed (see overdose warning)**  

adults and children 12 years and over

take 2 caplets every 6 hours while symptoms last

do not take more than 6 caplets in 24 hours, unless directed by a doctor

do not use for more than 10 days unless directed by a doctor

children under 12 years

ask a doctor

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 3/24/2025

Other information

store at 20-25°C (68-77°F)

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 1/3/2024

Inactive ingredients

carnauba wax, corn starch*, croscarmellose sodium*, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate*, stearic acid

*may contain one or more of these ingredients

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 3/24/2025

Questions or comments?

1-800-719-9260

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