Your browser does not support JavaScript! MENSTRUAL RELIEF (ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE) CAPSULE, LIQUID FILLED [WALGREEN CO.]
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MENSTRUAL RELIEF (acetaminophen, caffeine, pyrilamine maleate) capsule, liquid filled
[WALGREEN CO.]


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 gelcap)

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
  • backahe
  • breast tenderness
  • fatigue
  • muscle aches

Warnings

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

  • more than 8 gelcaps in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks 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, ask a doctor or pharmacist.

Ask a doctor before use if you have

  • difficulty in urination due to enlargmement of the prostate gland
  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis
  • blaucoma

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
  • excitability may occur, especially in children
  • be careful when driving a motor vehicle or operating machinery
  • avoid alcoholic drinks
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • 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 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 the reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick 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 (see overdose warning)
  • adults and children 12 years and older: take 2 gelcaps with water. Repeat every 6 hours, as needed. Do not exceed 8 gelcaps 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 controlled room temperature 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

Inactive ingredients

black iron oxide, cellulose, crocarmellose sodium, FD&C blue #1, gelatin, hypromellose, magnesium stearate, polyethylene glycol, povidone, silica gel, starch, stearic acid, titanium dioxide

Questions of comments?

1-800-426-9391

Product Packaging

 NDC 0363-0391-08

Walgreens

Compare to Midol® Complete

active ingredients*

MAXIMUM STRENGTH

MENSTRUAL

RELIEF

Acetaminophen 500 mg,

Caffeine 60 mg,

Pyrilamine maleate 15 mg

Relief of Menstrual Symptoms:

• Cramps • Bloating • Fatigue • Headaches • Backaches

SEE NEW WARNINGS INFORMATION

Aspirin Free

GELCAPS

24 GELCAPS

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

50844     REV0310J39108

Distributed by: Walgreen Co.,

200 Wilmot Rd.,

Deerfield, IL 60015-4616

Product Packaging

MENSTRUAL RELIEF 
acetaminophen, caffeine, pyrilamine maleate capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0363-0391
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
FERROSOFERRIC OXIDE 
POWDERED CELLULOSE 
CROSCARMELLOSE SODIUM 
FD&C BLUE NO. 1 
GELATIN 
HYPROMELLOSES 
MAGNESIUM STEARATE 
POLYETHYLENE GLYCOL 
POVIDONE 
SILICON DIOXIDE 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorBLUEScoreno score
ShapeCAPSULESize21mm
FlavorImprint Code 44;391
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-0391-081 in 1 CARTON
124 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34306/14/2001
Labeler - WALGREEN CO. (008965063)

Revised: 5/2011
 
WALGREEN CO.

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