Pain Aid PMF by Cintas Corporation / Ultra Seal Corporation / Ultratab Laboratories, Inc. Pain Aid PMF

Pain Aid PMF by

Drug Labeling and Warnings

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

Drug Details [pdf]

PAIN AID PMF- acetaminophen, pamabrom tablet 
Cintas Corporation

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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Pain Aid PMF

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 tablets every 6 hours, not more than 8 tablets 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

Principal Display Panel

Zee

painaid PMF

Premenstural Formula

PAIN AID PMF 
acetaminophen, pamabrom tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42961-046
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: 42961-046-03	50 in 1 CARTON	01/06/2021
1	NDC: 42961-046-02	125 in 1 CARTON
1	NDC: 42961-046-01	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	01/06/2021	12/27/2022

Labeler - Cintas Corporation (056481716)

Registrant - Ultra Seal Corporation (085752004)

Establishment
Name	Address	ID/FEI	Business Operations
Ultratab Laboratories, Inc.		151051757	manufacture(42961-046)

Revised: 12/2022

Document Id: 01e6d18f-61de-4b18-9430-7734391815a8

34390-5

Set id: 4da27724-57ed-4827-8c59-2479f9434c2d

Version: 2

Effective Time: 20221227