MENSTRUAL RELIEF MAXIMUM STRENGTH- acetaminophen, pamabrom, pyrilamine maleate tablet 
Western Family Foods, Inc.

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.

----------

DRUG FACTS

Active Ingredients (in each caplet)

Acetaminophen 500 mg
Pamabrom 25 mg
Pyrilamine Maleate 15 mg

Purpose

Pain Reliever
Diuretic
Antihistimine

Uses

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

  • cramps
  • headaches
  • bloating
  • backaches
  • water- weight gain
  • muscular aches
  • irritability

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 use

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

As 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. This could be a sign of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use

Keep out of reach of children.

Do not give to children under 3 years of age

Directions

  • adults and children 12 years of age and over: take 2 caplets with a full glass of water every 4-6 hours as needed
  • do not exceed 8 caplets in a 24 hour period or as directed by a doctor (see overdose warning)
  • children under 12 years of age: ask a doctor

Other information

  • store at room temperature 15o-30o C (59o-86o F)
  • do not use if imprinted safety seal under cap is broken or missing
  • *This product is not manufactured or distributed by Chattem Consumer Products, owner of the registered trademark Pamprin®

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.

Package label

Maximum strength Menstrual Relief

See new warnings information

Multi symptom

Cramps, headache, backache, bloating, irritability

Compare to PAMPRIN® active ingredients*

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Proudly distributed by:

Western Family Foods

PO Box 4057

Portland, OR 97208 USA

Questions or comments? Call toll free 1-877-753-3935

western family menstrual relief

Menstrual Relief caplets

MENSTRUAL RELIEF  MAXIMUM STRENGTH
acetaminophen, pamabrom, pyrilamine maleate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-947
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
PAMABROM (UNII: UA8U0KJM72) (BROMOTHEOPHYLLINE - UNII:FZG87K1MQ6) PAMABROM25 mg
PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE15 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MINERAL OIL (UNII: T5L8T28FGP)  
POVIDONE K15 (UNII: E54VE15114)  
STARCH, CORN (UNII: O8232NY3SJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorWHITE (WHITE) Scoreno score
ShapeCAPSULESize18mm
FlavorImprint Code CPC2826
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55312-947-401 in 1 BOX07/05/201012/31/2018
140 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34307/05/201012/31/2018
Labeler - Western Family Foods, Inc. (192166072)

Revised: 12/2018
 
Western Family Foods, Inc.