MENSTRUAL PAIN RELIEF MAXIMUM STRENGTH, MULTI-SYMPTOM- acetaminophen, pamabrom, pyrilamine maleate tablet, film coated 
CHAIN DRUG MARKETING ASSOCIATION 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.

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Quality Choice 44-369-Delisted

Active ingredients (in each caplet)

Acetaminophen 500 mg
Pamabrom 25 mg
Pyrilamine maleate 15 mg

Purpose

Pain reliever
Diuretic
Antihistamine

Uses

  • temporarily relieves these symptoms associated with menstrual periods:
    • cramps
    • headaches
    • bloating
    • backaches
    • water-weight gain
    • irritability
    • muscular 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 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

  • liver disease
  • glaucoma
  • trouble urinating due to an enlarged 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

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

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present

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 recommended 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. 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 caplets with water every 6 hours as needed
    • do not exceed 8 caplets in a 24-hour period or as directed by a doctor
  • children under 12 years: ask a doctor

Other information

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

Inactive ingredients

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

Questions or comments?

Call 1-800-426-9391

Principal display panel

QC®
QUALITY
CHOICE

NDC 63868-031-20

Compare to the
Active Ingredients in
PAMPRIN® MULTI-SYMPTOM*

Maximum Strength
Menstrual Pain Relief
Multi-Symptom

Acetaminophen - Pain Reliever
Pamabrom - Diuretic
Pyrilamine Maleate - Antihistamine
Relieves: Cramps, Irritability, Headache, Bloating, Backache

20 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
Chattem, Inc., owner of the registered trademark
Pamprin® Multi-Symptom.

50844        ORG101336909

SATISFACTION
GUARANTEED
100%
QC

Distributed by C.D.M.A., Inc.©
43157 W. Nine Mile
Novi, MI 48376-0995
www.qualitychoice.com
Questions: 248-449-9300

Quality Choice 44-369

Quality Choice 44-369

MENSTRUAL PAIN RELIEF  MAXIMUM STRENGTH, MULTI-SYMPTOM
acetaminophen, pamabrom, pyrilamine maleate tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-031
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 STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POVIDONES (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize18mm
FlavorImprint Code 44;369
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-031-201 in 1 CARTON
120 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34306/20/200001/19/2019
Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(63868-031)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(63868-031)

Revised: 1/2016
Document Id: 91b9fe69-295a-4af6-b436-fd3c16a2cd74
Set id: 7933d3f3-4f29-4f7f-a9aa-a7b51a2a126a
Version: 3
Effective Time: 20160119
 
CHAIN DRUG MARKETING ASSOCIATION INC