Your browser does not support JavaScript! PRE MENSTRUAL RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATE) TABLET [AMERISOURCE BERGEN]
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PRE MENSTRUAL RELIEF MAXIMUM STRENGTH (acetaminophen, pamabrom, pyrilamine maleate) tablet
[Amerisource Bergen]


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
Pamabrom 25 mg
Pyrilamine Maleate 15 mg

Purpose

Pain Reliever
Diuretic
Antihistimine/Diuretic

Uses

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

  • cramps
  • bloating
  • breast tenderness

Warnings

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

  • more than 4 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks everyday while using this product

Overdose warning: Taking more than the recommended dose (overdose) could cause serious health problems. 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 children even if you do not notice any signs or symptoms.

Do not exceed recommended dose.

Do not use

  • with other products 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

  • liver disease
  • glaucoma
  • difficulty in urination due to an 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 sedatives or tranquilizers
  • taking the blood thinning drug warfarin

When using this product

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

Stop use and ask a doctor if

  • new symptoms occur
  • redness or swelling is present
  • pain persists for more than 10 days.

If pregnant or breast-feeding,

ask a health professional before use

Keep out of reach of children.

Directions

  • do not take more than the recommended dose (See overdose warning)
  • adults and children 12 years of age and older: take 2 caplets with water
  • repeat every 6 hours, as needed
  • do not exceed 8 caplets per day
  • children under 12 years of age: consult a doctor

Other information

  • store at 15o-30o C (59o-86o F)
  • *This product is not manufactured or distributed by Bayer Healthcare LLC, owner of the registered trademark Midol®

Inactive Ingredients

croscarmellose sodium, hypromellose, magnesium silicate, magnesium stearate, microcrystalline celulose, mineral oil, polyvinylpyrrolidone, pregelatinized starch, silica, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide, and triacetin.

Questions or Comments?

Call toll free 1-877-753-3935

Package label

*Compare to Midol® Maximum strength Premenstrual Syndrome Formula active ingredients

See New Warnings Information

Maximum strength

Pre- Menstrual Relief

acetaminophen, pamabrom, pyrilamine maleate

pain reliever/ Diuretic/ Antihistamine

Cramps, Bloating, Breast Tenderness

THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Good Neighbor Pharmacy

Pre menstrual relief caplets

PRE MENSTRUAL RELIEF  MAXIMUM STRENGTH
acetaminophen, pamabrom, pyrilamine maleate tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:46122-021
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
PAMABROM (BROMOTHEOPHYLLINE) PAMABROM25 mg
PYRILAMINE MALEATE (PYRILAMINE) PYRILAMINE MALEATE15 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
HYPROMELLOSES 
MAGNESIUM SILICATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
MINERAL OIL 
POVIDONE K15 
STARCH, CORN 
SILICON DIOXIDE 
SODIUM LAURYL SULFATE 
SODIUM STARCH GLYCOLATE TYPE A CORN 
STEARIC ACID 
TITANIUM DIOXIDE 
TRIACETIN 
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize18mm
FlavorImprint Code CPC2826
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46122-021-622 in 1 CARTON
112 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34301/07/2011
Labeler - Amerisource Bergen (007914906)
Registrant - P and L Development of New York Corporation (800014821)

Revised: 11/2012
 
Amerisource Bergen

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