OTC Medication Information: Menstrual Complete

MENSTRUAL COMPLETE- acetaminophen, caffeine and pyrilamine maleate tablet, film coated
Topco Associates, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredients (in each caplet)

Acetaminophen 500 mg
Caffeine 60 mg
Pyrilamine maleate 15 mg

Purpose

Pain reliever
Diuretic
Antihistamine

Uses

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

  • bloating
  • headache
  • water-weight gain
  • cramps
  • backache
  • fatigue
  • muscle aches

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

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

  • 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

  • avoid alcoholic beverages

  • excitability may occur, especially in children
  • be careful when driving a motor vehicle or operating machinery

  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • you may get drowsy

  • 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 heartbeat. 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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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

  • do not take more than the recommended dose

  • 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

Other information

  • see end flap for expiration date and lot number

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

Inactive ingredients

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

Questions or comments?

1-888-423-0139

Principal display panel

TopCare®
health

COMPARE TO
MIDOL® COMPLETE
ACTIVE INGREDIENTS*

NDC 36800-391-08

MAXIMUM STRENGTH

Menstrual Complete

ACETAMINOPHEN , CAFFEINE, PYRILAMINE MALEATE
PAIN RELIEVER • DIURETIC • ANTIHISTAMINE

MULTI-SYMPTOM RELIEF OF:
• Cramps • Headache • Bloating
• Backache • Fatigue

24 CAPLETS

actual
size

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 ORG051739008

QUALITY GUARANTEED

DISTRIBUTED BY
TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL
60007
©TOPCO LNKA1018
QUESTIONS?
1-888-423-0139
topcare@topco.comwww.topcarebrand.com

Topcare 44-390
(click image for full-size original)

Topcare 44-390

MENSTRUAL COMPLETE acetaminophen, caffeine, pyrilamine maleate tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-391
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
CAFFEINE (CAFFEINE) CAFFEINE 60 mg
PYRILAMINE MALEATE (PYRILAMINE) PYRILAMINE MALEATE 15 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
CROSCARMELLOSE SODIUM
CROSPOVIDONE
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYDEXTROSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE
SILICON DIOXIDE
STEARIC ACID
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 17mm
Flavor Imprint Code 44;390
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36800-391-08 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC This package is contained within the CARTON (36800-391-08)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part343 01/01/2019
Labeler — Topco Associates, LLC (006935977)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 038154464 PACK (36800-391)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867894 MANUFACTURE (36800-391)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867837 PACK (36800-391)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 967626305 PACK (36800-391)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 868734088 PACK (36800-391)

Revised: 11/2019 Topco Associates, LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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