MedPath
FDA Approval

MENSTRUAL COMPLETE

Rite Aid Corporation (DUNS: 014578892)

June 12, 2025

HUMAN OTC DRUG LABEL

Acetaminophen(500 mg in 1 1)
Caffeine(60 mg in 1 1)
Pyrilamine Maleate(15 mg in 1 1)

Manufacturing Establishments (1)

LNK International, Inc.

Rite Aid Corporation

117025878

Products (1)

MENSTRUAL COMPLETE

11822-3900

M013

OTC Monograph Drug (C200263)

ORAL

June 12, 2025

Code: 362O9ITL9DClass: ACTIBQuantity: 500 mg in 1 1
CaffeineActive
Code: 3G6A5W338EClass: ACTIBQuantity: 60 mg in 1 1
Code: R35D29L3ZAClass: ACTIBQuantity: 15 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IEClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Uses

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

  • bloating

  • headache

  • water-weight gain

  • cramps

  • backache

  • fatigue

  • muscle aches

DOSAGE & ADMINISTRATION SECTION

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

WARNINGS SECTION

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.


STORAGE AND HANDLING SECTION

Other information

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

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each caplet)

Acetaminophen 500 mg
Caffeine 60 mg
Pyrilamine maleate 15 mg

OTC - PURPOSE SECTION

Purpose

Pain reliever
Diuretic
Antihistamine

OTC - QUESTIONS SECTION

Questions or comments?

1-800-426-9391


INACTIVE INGREDIENT SECTION

Inactive ingredients

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


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