PAIN AID PMF- acetaminophen, pamabrom tablet

Pain Aid PMF by

Drug Labeling and Warnings

Pain Aid PMF by is a Otc medication manufactured, distributed, or labeled by Zee Medical Inc, Ultra Seal Corporation, Ultratab Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

Purpose-Pain Reliever, Diuretic

INDICATIONS & USAGE

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

DOSAGE & ADMINISTRATION

Directions

• adults: take 2 tablets every 6 hours, not more than 8 tablets in 24 hours

• children under 12 years: ask a doctor

WARNINGS

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

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

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 INGREDIENT

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

PRINCIPAL DISPLAY PANEL

MM11

INGREDIENTS AND APPEARANCE

PAIN AID PMF 
acetaminophen, pamabrom tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35418-710
Route of Administration	ORAL

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: 2S7830E561)
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	06/12/2012
1	NDC: 35418-710-67	125 in 1 CARTON
1	NDC: 35418-710-02	2 in 1 PACKET; Type 0: Not a Combination Product

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)