FEMADRINE- acetaminophen, pamabrom tablet 
Afassco 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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Drug Facts

Acetaminophen 325mg

Pamabrom 25mg

Pain reliever, Diuretic

Uses: For the relief of:

• cramps • bloating • water-weight gain

• headaches • backaches • muscular aches and pains

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

Keep out of reach of children.

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

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.

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.

SEE ORIGINAL BOX FOR COMPLETE PRODUCT INFORMATION

AfasscoFemadrine12-16

FEMADRINE 
acetaminophen, pamabrom tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51532-0700
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 
PAMABROM (UNII: UA8U0KJM72) (BROMOTHEOPHYLLINE - UNII:FZG87K1MQ6) PAMABROM25 
Inactive Ingredients
Ingredient NameStrength
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
Colorwhite (with red and green crystals) Scoreno score
ShapeROUNDSize11mm
FlavorImprint Code FR7
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51532-0700-22 in 1 PACKET; Type 0: Not a Combination Product10/25/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34310/25/2016
Labeler - Afassco Inc. (609982723)

Revised: 11/2016
Document Id: 6d7e1de6-5bd9-4d60-abd3-f20281c28af6
Set id: 326f1c99-15d4-40c5-b356-8bad252b3319
Version: 2
Effective Time: 20161128
 
Afassco Inc.