FEMADRINE- acetaminophen, pamabrom tablet

Femadrine by

Drug Labeling and Warnings

Femadrine by is a Otc medication manufactured, distributed, or labeled by Afassco Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Acetaminophen 325mg

Pamabrom 25mg

PURPOSE

Pain reliever, Diuretic

INDICATIONS & USAGE

Uses: For the relief of:

cramps bloating water-weight gain

headaches backaches muscular aches and pains

WARNINGS

Warnings:

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 8 tablets in 24 hours

with any other drugs containing acetaminophen (prescription or non-prescription).

3 or more alcoholic drinks a while using this product.

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

PREGNANCY OR BREAST FEEDING

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

OVERDOSAGE

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.

DOSAGE & ADMINISTRATION

Directions: Do not use more than directed.

Adults and children: (12 years and older) Take 2 tablets with water. Repeat every 4 hours, as needed, not to exceed 8 tablets in any 24 hour period.

Children under 12 years of age: Consult a doctor.

INACTIVE INGREDIENT

SEE ORIGINAL BOX FOR COMPLETE PRODUCT INFORMATION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FEMADRINE 
acetaminophen, pamabrom tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51532-0700
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
RAW SUGAR (UNII: 8M707QY5GH)

Product Characteristics
Color	white (with red and green crystals)	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	FR7
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51532-0700-2	2 in 1 PACKET; Type 0: Not a Combination Product	10/25/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	10/25/2016

Labeler - Afassco Inc. (609982723)