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 Type HUMAN OTC DRUG Item Code (Source) NDC:35418-710
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg
PAMABROM (UNII: UA8U0KJM72) (BROMOTHEOPHYLLINE - UNII:FZG87K1MQ6) PAMABROM 25 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CROSPOVIDONE (UNII: 68401960MK)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POVIDONE K29/32 (UNII: 390RMW2PEQ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Product Characteristics
Color pink (rose pink) Score no score
Shape CAPSULE (ZEE;PM) Size 18mm
Flavor Imprint Code ZEE;PM
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:35418-710-68 50 in 1 CARTON
1 NDC:35418-710-67 125 in 1 CARTON
1 NDC:35418-710-02 2 in 1 PACKET
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 06/12/2012
Labeler - Zee Medical Inc (009645623)
Registrant - Ultra Seal Corporation (085752004)
Establishment
Name Address ID/FEI Business Operations
Ultratab Laboratories, Inc. 151051757 manufacture(35418-710)
Establishment
Name Address ID/FEI Business Operations
Ultra Seal Corporation 085752004 repack(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