FEM RELIEF- acetaminophen pamabrom tablet 
Honeywell Safety Products USA, 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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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
OTC monograph not finalpart34301/01/201712/29/2022
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
OTC monograph not finalpart34302/15/201201/01/2017
Labeler - Honeywell Safety Products USA, Inc (118768815)

Revised: 12/2022
Document Id: f0ec8857-2a42-6c1f-e053-2a95a90a39c3
Set id: 1be326af-0a12-4a69-be5d-32bbffc6dbad
Version: 11
Effective Time: 20221228
 
Honeywell Safety Products USA, Inc