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Rite Aid 44-390

Approved
Approval ID

de723b85-011c-4014-82a8-e813460e3f12

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jun 12, 2025

Manufacturers
FDA

Rite Aid Corporation

DUNS: 014578892

Products 1

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

Acetaminophen, Caffeine, Pyrilamine maleate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code11822-3900
Application NumberM013
Product Classification
M
Marketing Category
C200263
G
Generic Name
Acetaminophen, Caffeine, Pyrilamine maleate
Product Specifications
Route of AdministrationORAL
Effective DateJune 12, 2025
FDA Product Classification

INGREDIENTS (16)

ACETAMINOPHENActive
Quantity: 500 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
CAFFEINEActive
Quantity: 60 mg in 1 1
Code: 3G6A5W338E
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
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/12/2025

Principal Display Panel

NDC 11822-3900-8

Compare to active ingredients inMidol****®**** Complete*

MENSTRUAL COMPLETE
** ACETAMINOPHEN,**CAFFEINE, PYRILAMINE MALEATE
pain reliever • diuretic • antihistamine

MULTI-SYMPTOM RELIEF
****of cramps, bloating, fatigue,
headache & backache

ACTUAL SIZE

24
CAPLETS

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

*This product is not manufactured or distributed by
Bayer HealthCare LLC, owner of the registered
trademark Midol® Complete.

50844 ORG062339008

DISTRIBUTED BY: RITE AID,
200 NEWBERRY COMMONS
ETTERS, PA 17319www.riteaid.com

SATISFACTION
** GUARANTEE**
If you’re not satisfied, we’ll
happily refund your money.

Rite Aid 44-390

Rite Aid 44-390

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 6/12/2025

Uses

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

  • bloating

  • headache

  • water-weight gain

  • cramps

  • backache

  • fatigue

  • muscle aches

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 6/12/2025

Active ingredients (in each caplet)

Acetaminophen 500 mg
Caffeine 60 mg
Pyrilamine maleate 15 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 6/12/2025

Purpose

Pain reliever
Diuretic
Antihistamine

WARNINGS SECTION

LOINC: 34071-1Updated: 6/12/2025

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
  • liver disease
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When using this product

  • drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
  • use caution when driving a motor vehicle or operating machinery
  • 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 heart rate. The recommended dose of this product contains about as much caffeine as a cup of coffee.

Stop use and ask a doctor if

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

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 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: 6/12/2025

Directions

*do not take more than directed

  • adults and children 12 years and over:
    • take 2 caplets with water
    • repeat every 6 hours, as needed
    • do not exceed 6 caplets per day
  • children under 12 years: ask a doctor

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 6/12/2025

Other information

  • see end flap for expiration date and lot number
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 6/12/2025

Inactive ingredients

corn starch, croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, silicon dioxide, stearic acid, titanium dioxide, triacetin

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 6/12/2025

Questions or comments?

1-800-426-9391

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MENSTRUAL COMPLETE - FDA Drug Approval Details