PAIN AID PMF - acetaminophen and pamabrom tablet 
Zee Medical 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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Drug Facts

Active Ingredient (in each tablet)  Acetaminophen 500mg, Pamabrom 25 mg

Purpose-Pain Reliever, Diuretic

Uses
temporarily relieves the following menstrual and premenstrual symptoms:
■ water-weight gain ■ bloating
■ backache ■ headache ■ minor pain of menstrual and premenstrual cramps

Directions ■ adults: take 2 caplets every 6 hours, not more than 8 caplets in 24 hours ■ children under 12 years: ask a doctor

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
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
Stop use and ask a doctor if
■ pain lasts more than 10 days or gets worse
■ redness or swelling is present in the painful area
■ any new symptoms appear

If pregnant or breast-feeding baby, ask a health professional  
before use

KEEP OUT OF REACH OF CHILDREN. 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 for  
children even if you do not notice any signs or symptoms.

Inactive ingredients
croscarmellose sodium, crospovidone, FDC red 40 aluminum lake, hydroxypropyl methylcellulose, maltodextrin*, magnesium
stearate*, microcrystalline cellulose, polyethylene glycol, polysorbate 80*, povidone, sodium starch glycolate*, starch, stearic acid,
titanium dioxide
*contains one or more of these ingredients

MM1PMF 250 Box 1

PAIN AID PMF 
acetaminophen, pamabrom tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:35418-710
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
PAMABROM (BROMOTHEOPHYLLINE) PAMABROM25 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
CROSPOVIDONE 
MAGNESIUM STEARATE 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 3350 
POLYSORBATE 80 
POVIDONE K29/32 
TITANIUM DIOXIDE 
STEARIC ACID 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
FD&C RED NO. 40 
Product Characteristics
Colorpink (rose pink) Scoreno score
ShapeCAPSULE (ZEE;PM) Size18mm
FlavorImprint Code ZEE;PM
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35418-710-6850 in 1 CARTON
1NDC:35418-710-67125 in 1 CARTON
1NDC:35418-710-022 in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34306/12/2012
Labeler - Zee Medical Inc (009645623)
Registrant - Ultra Seal Corporation (085752004)
Establishment
NameAddressID/FEIBusiness Operations
Ultratab Laboratories, Inc.151051757manufacture(35418-710)
Establishment
NameAddressID/FEIBusiness Operations
Ultra Seal Corporation085752004repack(35418-710)

Revised: 11/2012
Document Id: f6ad4ae3-238c-4340-a5e1-3db7a2886533
Set id: a5d0dce4-ee28-4849-8a1f-06600e8d5d95
Version: 1
Effective Time: 20121112
 
Zee Medical Inc