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Fem Relief

Dosage form: tablet
Ingredients: ACETAMINOPHEN 325mg, PAMABROM 25mg
Labeler: North Safety Products LLC
NDC Code: 0498-7001

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.

Fem Relief

Active ingredient (in each tablet)

Acetaminophen 500 mg

Pamabrom 25 mg

Purpose

Pain reliever/diuretic

Uses

for the relief of

  • pain of the premenstrual and menstrual periods
  • pain of dysmenorrhea
  • temporary weight gain, bloating, swelling and/or full feeling associated with the premenstrual and menstrual periods

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

more than 8 tablets 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

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening
blisters
rash

If a skin reaction occurs, stop use and seek medical help right away.

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.
  • for more than 10 days for pain unless directed by a doctor
  • for more than 3 days for fever unless directed by a doctor

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 using and ask a doctor if
  • symptoms do not improve
  • new symptoms occur
  • pain or fever persists or gets worse

If pregnant or breast-feeding

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

Keep out of reach of children

Keep out of the reach of children. In case of accidental 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.

Directions
  • Adults and Children 12 years of age and over:
  • take 2 tablets with water every 4 hours while symptoms persist, not to exceed 8 tablets in 24 hours.
  • Children under 12: consult a doctor

Other information
  • salt free
  • sugar free
  • antihistamine free
  • caffeine free
  • store at room temperature
  • tamper evident, do not use if packet is torn or open

Inactive ingredients

corn starch, D&C yellow #10, FD&C Blue #1, microcrystalline cellulose, povidone, stearic acid

Questions or comments?

1-800-430-5490

MM1

Fem Relief label

FEM RELIEF 
acetaminophen pamabrom tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-7001
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
PAMABROM (BROMOTHEOPHYLLINE) PAMABROM25 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 
FD&C BLUE NO. 1 
D&C YELLOW NO. 10 
STARCH, CORN 
SUCROSE 
POVIDONE 
STEARIC ACID 
CELLULOSE, MICROCRYSTALLINE 
Product Characteristics
Colorwhite (WHITE W RED AND GREEN SPOTS) Scoreno score
ShapeROUND (FR7) Size11mm
FlavorImprint CodeFR7
Contains    
Packaging
#Item CodePackage Description
1NDC:0498-7001-25250 PACKET in 1 BOX
1NDC:0498-7001-012 TABLET in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34301/01/2017
FEM RELIEF 
acetaminophen pamabrom tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-7000
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
PAMABROM (BROMOTHEOPHYLLINE) PAMABROM25 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
SUCROSE 
POVIDONE 
STEARIC ACID 
CELLULOSE, MICROCRYSTALLINE 
FD&C RED NO. 40 
FD&C BLUE NO. 1 
D&C YELLOW NO. 10 
Product Characteristics
Colorwhite (WHITE W RED AND GREEN SPOTS) Scoreno score
ShapeROUND (FR7) Size11mm
FlavorImprint CodeFR7
Contains    
Packaging
#Item CodePackage Description
1NDC:0498-7000-50250 BOX in 1 BOX
1NDC:0498-7000-25125 BOX in 1 BOX
1NDC:0498-7000-1050 PACKET in 1 BOX
1NDC:0498-7000-012 TABLET in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34302/15/201201/01/2017
Labeler - North Safety Products LLC (019777263)
Registrant - North Safety Products LLC (019777263)
Establishment
NameAddressID/FEIOperations
North Safety Products LLC019777263repack(0498-7000, 0498-7001)
Establishment
NameAddressID/FEIOperations
Ultra Seal Corporation085752004pack(0498-7000, 0498-7001)
Establishment
NameAddressID/FEIOperations
ULTRAtab Laboratories, Inc.151051757manufacture(0498-7000, 0498-7001)

Revised: 12/2017
 
North Safety Products LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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