Medi First Cramp

Medi First Cramp

Drug Labeling and Warnings

Drug Details

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MEDI FIRST CRAMP- acetaminophen, pamabrom tablet, film coated 
MEDI FIRST PLUS CRAMP- acetaminophen, pamabrom tablet, film coated 
Unifirst First Aid Corporation

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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Medi First Cramp

Drug Facts

Active ingredients (in each tablet)

Acetaminophen 325 mg

Pamabrom 25 mg

Purpose

Pain reliever/fever reducer

Diuretic

Uses

For the temporary relief of minor aches and pains associated with

  • headache
  • backaches
  • menstrual cramps

Temporarily relieves water-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 4,000 mg of acetaminophen in 24 hours

■ with other drugs containing acetaminophen

■ 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

  • symptoms do not improve
  • new symptoms occur
  • pain or fever persists or gets worse
  • redness or swelling is present

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

Keep out of reach of children. 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 use more than directed

Adults and children: (12 years and older)

Take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours.

Children under 12 years:

Do not give to children under 12 years of age.

Other information

  • read all product information before using
  • store at room temperature 59º-86ºF (15º-30ºC)
  • avoid excessive heat and humidity
  • tamper-evident sealed packets
  • do not use any opened or torn packets

Inactive ingredients

corn starch, D&C yellow #10, FD&C blue #1, FD&C red #40, microcrystalline cellulose, povidone, stearic acid, sucrose

Questions or comments?

1-800-634-7680

Medi-First Plus Cramp Tabs Label

100 Tablets

(50 x 2's)

Medi First® Plus

Cramp Tabs

Acetaminophen 325 mg / Pamabrom 25 mg

Pull to Open

Menstrual Relief

Tamper Evident Unit Dose Packets

Medi-First Plus

Principal Display Panel MF Cramp Tabs

100 Tablets

(50 x 2)

Medi-First®

Cramp Tabs

Menstrual Pain Relief

Pull to Open

Pain Reliever Acetaminophen 325 mg

Diuretic Pamabrom 25 mg

Tamper Evident

Unit Dose Packets

edi-First Cramp Tabs

MEDI FIRST CRAMP 
acetaminophen, pamabrom tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 47682-810
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
CELLULOSE, MICROCRYSTALLINE (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)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
Colorwhite (white) Scoreno score
ShapeROUND (ROUND) Size11mm
FlavorImprint Code FR;7
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 47682-810-3350 in 1 BOX12/30/2008
12 in 1 PACKET; Type 0: Not a Combination Product
2NDC: 47682-810-48125 in 1 BOX12/30/2008
22 in 1 PACKET; Type 0: Not a Combination Product
3NDC: 47682-810-13250 in 1 BOX12/30/2008
3NDC: 47682-810-992 in 1 PACKET; Type 0: Not a Combination Product
4NDC: 47682-810-992 in 1 PACKET; Type 0: Not a Combination Product12/30/2008
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34312/30/2008
MEDI FIRST PLUS CRAMP 
acetaminophen, pamabrom tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 47682-910
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
CELLULOSE, MICROCRYSTALLINE (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)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
Colorwhite (white) Scoreno score
ShapeROUND (ROUND) Size11mm
FlavorImprint Code FR;7
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 47682-910-3350 in 1 BOX12/30/2008
12 in 1 PACKET; Type 0: Not a Combination Product
2NDC: 47682-910-48125 in 1 BOX12/30/2008
22 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34312/30/2008
Labeler - Unifirst First Aid Corporation (832947092)
Establishment
NameAddressID/FEIBusiness Operations
Prestige Packaging170837962relabel(47682-810, 47682-910) , repack(47682-810, 47682-910)

Revised: 4/2019
 
Unifirst First Aid Corporation


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