Your browser does not support JavaScript! MENSTRUAL COMPLETE (ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE) TABLET [WAL-MART STORES INC]
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MENSTRUAL COMPLETE (acetaminophen, caffeine and pyrilamine maleate) tablet
[Wal-Mart Stores Inc]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

Active ingredients (in each caplet)

Acetaminophen 500 mg
Caffeine 60 mg
Pyrilamine maleate 15 mg

Purpose

Pain reliever
Stimulant
Diuretic

Uses

  • for the temporary relief of these symptoms associated with menstrual periods:
    • cramps
    • bloating
    • water-weight gain
    • headache
    • backache
    • breast tenderness
    • fatigue
    • muscle aches

Warnings

 Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 8 caplets in 24 hours, which is the maximum daily ammount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinnks every day while using this product

Do not use

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

Ask a doctor before use if you have

  • liver disease
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
  • 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

  • you may get drowsy
  • avoid alcoholic drinks
  • excitability may occur, especially in children
  • alcohol, sedatives and tranqulizers may increase drowsiness
  • be careful 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, occassionally, 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 appear
  • redness or swelling is present
  • pain gets worse or lasts more than 10 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

Overdose warning: Taking more than the reocmmended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

  • do not take more than the recommended dose
    (see overdose warning)
  • adults and children 12 years and older: take 2 caplets with water. Repeat every 6 hours, as needed. Do not exceed 8 caplets in 24 hours.
  • children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Other information

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

Inactive ingredients

corn starch, croscarmellose sodium, crospovidone, hypromellose, magnesium sterate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, silica gel, stearic acid, titanium dioxide, triacetin

Principal Display Panel

equate®

NDC 49035-390-10

Compare to Midol® Complete Active Ingredients*

Maximum Strength
Menstrual Complete
Acetaminophen
, Caffeine, Pyrilamine maleate
Pain Reliever/Stimulant/Diuertic

Multi-Symptom Relief of:
• Cramps
• Bloating
• Fatigue
• Backache & Headache

40
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    REV0612A39010

Equate 44-390

Equate 44-390

MENSTRUAL COMPLETE 
acetaminophen, caffeine and pyrilamine maleate tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:49035-390
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
CAFFEINE (CAFFEINE) CAFFEINE60 mg
PYRILAMINE MALEATE (PYRILAMINE) PYRILAMINE MALEATE15 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
HYPROMELLOSES 
MAGNESIUM STEARATE 
POLYDEXTROSE 
POLYETHYLENE GLYCOLS 
STEARIC ACID 
TITANIUM DIOXIDE 
TRIACETIN 
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize17mm
FlavorImprint Code 44;390
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49035-390-081 in 1 CARTON
124 in 1 BLISTER PACK
2NDC:49035-390-101 in 1 CARTON
240 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34304/29/2002
Labeler - Wal-Mart Stores Inc (051957769)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(49035-390)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(49035-390)

Revised: 4/2013
 
Wal-Mart Stores Inc

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