FEM RELIEF- acetaminophen pamabrom tablet 
Honeywell Safety Products USA, Inc

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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0498-7001 & 0498-7000: Fem Relief

Active ingredient (in each tablet)

Acetaminophen 325 mg

Pamabrom 25 mg

Purpose

Pain reliever/fever reducer

Diuretic

Uses

temporarily relieves

  • premenstrual and menstrual cramps
  • minor aches and pains and temporary weight gain, bloating, swelling, and 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
  • taken with other drugs containing acetaminophen
  • adult has 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

  • new symptoms occur
  • redness or swelling is present

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.

Overdose warning: 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

  • do not take more than directed (see overdose warning)
  • 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

  • store at room temperature
  • salt free
  • sugar free
  • antihistamine free
  • caffeine free
  • TAMPER EVIDENT PACKETS-DO NOT USE IF OPEN OR TORN

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 100 Packet Box

Fem Relief label

Honeywell FemRelief

FEM RELIEF 
acetaminophen pamabrom tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-7001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
PAMABROM (UNII: UA8U0KJM72) (BROMOTHEOPHYLLINE - UNII:FZG87K1MQ6) PAMABROM25 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
STARCH, CORN (UNII: O8232NY3SJ)  
SUCROSE (UNII: C151H8M554)  
POVIDONE (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
Colorwhite (WHITE W RED AND GREEN SPOTS) Scoreno score
ShapeROUND (FR7) Size11mm
FlavorImprint Code FR7
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-7001-25250 in 1 BOX01/02/2017
1NDC:0498-7001-012 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/01/201712/29/2022
FEM RELIEF 
acetaminophen pamabrom tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-7000
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
PAMABROM (UNII: UA8U0KJM72) (BROMOTHEOPHYLLINE - UNII:FZG87K1MQ6) PAMABROM25 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
SUCROSE (UNII: C151H8M554)  
POVIDONE (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
Product Characteristics
Colorwhite (WHITE W RED AND GREEN SPOTS) Scoreno score
ShapeROUND (FR7) Size11mm
FlavorImprint Code FR7
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-7000-50250 in 1 BOX02/15/201201/01/2017
1NDC:0498-7000-25125 in 1 BOX
1NDC:0498-7000-1050 in 1 BOX
1NDC:0498-7000-012 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/15/201201/01/2017
Labeler - Honeywell Safety Products USA, Inc (118768815)

Revised: 1/2024
Document Id: 0ecabbee-c5b4-f0ed-e063-6394a90a98a4
Set id: 1be326af-0a12-4a69-be5d-32bbffc6dbad
Version: 12
Effective Time: 20240112
 
Honeywell Safety Products USA, Inc