MedPath

Menstrual Relief

Quality Plus 44-679

Approved
Approval ID

92bb5cf5-5861-4f5e-91f7-9a546563c18e

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 20, 2025

Manufacturers
FDA

L.N.K. International, Inc.

DUNS: 038154464

Products 1

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

Acetaminophen, Pamabrom, Pyrilamine maleate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50844-679
Application NumberM013
Product Classification
M
Marketing Category
C200263
G
Generic Name
Acetaminophen, Pamabrom, Pyrilamine maleate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 20, 2025
FDA Product Classification

INGREDIENTS (18)

ACETAMINOPHENActive
Quantity: 500 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
PAMABROMActive
Quantity: 25 mg in 1 1
Code: UA8U0KJM72
Classification: ACTIB
PYRILAMINE MALEATEActive
Quantity: 15 mg in 1 1
Code: R35D29L3ZA
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
FD&C BLUE NO. 2 ALUMINUM LAKEInactive
Code: 4AQJ3LG584
Classification: IACT
FD&C RED NO. 40 ALUMINUM LAKEInactive
Code: 6T47AS764T
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/20/2025

Principal Display Panel

QUALITY
+PLUS

NDC 50844-679-27

*Compare to active ingredients in
Maximum Strength Pamprin®
Multi-Symptom

MAXIMUM STRENGTH
MENSTRUAL RELIEF

PAIN RELIEVER, DIURETIC, ANTIHISTAMINE
Acetaminophen, Pamabrom, Pyrilamine maleate

ASPIRIN/CAFFEINE FREE
Multi-Symptom

32 Caplets

ACTUAL
SIZE

*This product is not manufactured or distributed
by Focus Consumer Healthcare, LLC, owner of the
registered trademark Maximum Strength Pamprin®
Multi-Symptom. 50844 REV0718A67927

Distributed by
LNK INTERNATIONAL, INC.
60 Arkay Drive
Hauppauge, NY 11788
USA

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

![Quality Plus 44-679](/dailymed/image.cfm?name=quality- plus-44-679-1.jpg&id=894045)

Quality Plus 44-679



INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/20/2025

Uses

for the temporary relief of these symptoms associated with menstrual periods:

  • headache

  • bloating

  • cramps

  • backache

  • muscular aches

  • irritability

  • water-weight gain

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/20/2025

Active ingredients (in each caplet)

Acetaminophen 500 mg
Pamabrom 25 mg
Pyrilamine maleate 15 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/20/2025

Purpose

Pain reliever
Diuretic
Antihistamine

WARNINGS SECTION

LOINC: 34071-1Updated: 8/20/2025

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

  • difficulty in urination due to enlargement of the prostate gland

  • a breathing problem such as emphysema or chronic bronchitis

  • liver disease

  • glaucoma

Ask a doctor or pharmacist before use if you are

  • taking sedatives or tranquilizers

  • taking the blood thinning drug warfarin

When using this product

  • drowsiness may occur

  • avoid alcoholic beverages

  • excitability may occur, especially in children

  • alcohol, sedatives and tranquilizers may increase drowsiness

  • use caution when driving a motor vehicle or operating machinery

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.

In case of accidental 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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/20/2025

Directions

*do not take more than directed

  • adults and children 12 years and over:

    • take 2 caplets with water every 6 hours as needed

    • do not exceed 6 caplets in a 24 hour period or as directed by a doctor

  • children under 12 years: ask a doctor

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 8/20/2025

Other information

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

  • see end flap for expiration date and lot number

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/20/2025

Inactive ingredients

corn starch, croscarmellose sodium, crospovidone, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, shellac wax, silicon dioxide, stearic acid, talc, titanium dioxide

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 8/20/2025

Questions or comments?

1-800-426-9391

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.