CRAMP TABS- acetaminophen, pamabrom tablet 
ADVANCED FIRST AID, 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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ACTIVE INGREDIENT IN EACH TABLET- ACETAMINOPHEN 250 MG, pamabrom 25 MG

PAIN RELIEVER/FEVER REDUCER WITH Diuretic

Uses: For the relief of:

Warnings:

Liver Warning:

This product contains Acetaminophen. Severe liver damage may occur if:

•you take more than 8 tablets in 24 hours • you take with other drugs containing acetaminophen (prescription

or non-prescription)

• you have 3 or more alcoholic drinks every day while using this product

Precaution: If a rare sensitivity reaction occurs, the drug should be discontinued.

Do not use:

• with any other product containing acetaminophen this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns.

• for more than 10 days for pain unless directed by a doctor

Stop use and ask a doctor if:

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

KEEP OUT OF REACH OF CHILDREN. 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.

Adults and children 12 years of age and older:Take 2 tablets every 4-6 hours as

 needed. Do not exceed 8 tablets in any 24 hour period, or as directed by a doctor.

Children under 12 years: Consult a doctor.

Inactive Ingredients: corn starch, microcrystalline cellulose, povidone, sodium starch glycolate, and stearic acid.

Advanced first aid cramp tabs

CRAMP TABS 
acetaminophen, pamabrom tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67060-700
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
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE K30 (UNII: U725QWY32X)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
sodium starch glycolate type a corn (UNII: AG9B65PV6B)  
Product Characteristics
Colorwhite (SNOW WHITE) Scoreno score
ShapeCAPSULESize11mm
FlavorImprint Code FEM
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67060-700-68100 in 1 CARTON08/10/2015
12 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34308/10/2015
Labeler - ADVANCED FIRST AID, INC. (114477180)
Registrant - ADVANCED FIRST AID, INC. (114477180)
Establishment
NameAddressID/FEIBusiness Operations
ULTRA SEAL CORPORATION085752004pack(67060-700)
Establishment
NameAddressID/FEIBusiness Operations
ULTRA TAB LABORATORIES, INC.151051757manufacture(67060-700)

Revised: 8/2015
Document Id: 158f7716-2b9a-42f1-be9a-d9652258301f
Set id: 3e6822a7-58ff-4778-a24e-7d9e8ecb1d33
Version: 1
Effective Time: 20150810
 
ADVANCED FIRST AID, INC.