FEM RELIEF- acetaminophen pamabrom tablet

Fem Relief by

Drug Labeling and Warnings

Fem Relief by is a Otc medication manufactured, distributed, or labeled by Honeywell Safety Products USA, Inc, NORTH SAFETY DE MEXICALI, S. DE R.I. DE C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

MM1

Fem Relief label

INGREDIENTS AND APPEARANCE

FEM RELIEF 
acetaminophen pamabrom tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0498-7001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
PAMABROM (UNII: UA8U0KJM72) (BROMOTHEOPHYLLINE - UNII:FZG87K1MQ6)	PAMABROM	25 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	white (WHITE W RED AND GREEN SPOTS)	Score	no score
Shape	ROUND (FR7)	Size	11mm
Flavor		Imprint Code	FR7
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-7001-25	250 in 1 BOX	01/02/2017
1	NDC: 0498-7001-01	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	01/01/2017

FEM RELIEF 
acetaminophen pamabrom tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0498-7000
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
PAMABROM (UNII: UA8U0KJM72) (BROMOTHEOPHYLLINE - UNII:FZG87K1MQ6)	PAMABROM	25 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	white (WHITE W RED AND GREEN SPOTS)	Score	no score
Shape	ROUND (FR7)	Size	11mm
Flavor		Imprint Code	FR7
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-7000-50	250 in 1 BOX	02/15/2012	01/01/2017
1	NDC: 0498-7000-25	125 in 1 BOX
1	NDC: 0498-7000-10	50 in 1 BOX
1	NDC: 0498-7000-01	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	02/15/2012	01/01/2017

Labeler - Honeywell Safety Products USA, Inc (079287321)

Registrant - Honeywell Safety Products USA, Inc (079287321)

Establishment
Name	Address	ID/FEI	Business Operations
Honeywell Safety Products USA, Inc		079287321	repack(0498-7000, 0498-7001)