CVS 44-679

CVS 44-679

Drug Labeling and Warnings

Drug Details

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PMS RELIEF MAXIMUM STRENGTH- acetaminophen, pamabrom, pyrilamine maleate tablet, film coated 
CVS Pharmacy

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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CVS 44-679

Active ingredients (in each caplet)

Acetaminophen 500 mg
Pamabrom 25 mg
Pyrilamine maleate 15 mg

Purpose

Pain reliever
Diuretic
Antihistamine

Uses

for the temporary relief of these symptoms associated with menstrual periods:

  • headache
  • bloating
  • cramps
  • backache
  • muscular aches
  • irritability
  • water-weight gain

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 4,000 mg in 24 hours, which is the maximum daily amount
  • 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.
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

  • difficulty in urination due to enlargement of the prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • liver disease
  • glaucoma

Ask a doctor or pharmacist before use if you are

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

When using this product

  • you may get drowsy
  • avoid alcoholic beverages
  • excitability may occur, especially in children
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present

These could be signs of a serious condition.

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 (1-800-222-1222) 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 the recommended dose
  • adults and children 12 years and over:
    • take 2 caplets with water every 6 hours as needed
    • do not exceed 8 caplets in a 24 hour period or as directed by a doctor
  • children under 12 years: ask a doctor

Other information

  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

Inactive ingredients

corn starch, croscarmellose sodium, crospovidone, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, shellac wax, silicon dioxide, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-426-9391

Principal display panel

CVSHealth

Compare to the active ingredients in Maximum Strength Pamprin® Multi-Symptom*

NDC: 59779-879-08

MAXIMUM STRENGTH

PMS Relief
ACETAMINOPHEN
500 mg
PAMABROM 25 mg, PYRILAMINE MALEATE 15 mg
Pain reliever, Diuretic, Antihistamine

Multi-symptom

Relieves the symptoms of premenstrual
syndrome: cramps, bloating, headache,
backache and water-weight gain

24 COATED CAPLETS

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Maximum Strength Pamprin® Multi-Symptom.

50844 REV1116A67908

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
©2017 CVS/pharmacy
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CVS 44-679

CVS 44-679


PMS RELIEF  MAXIMUM STRENGTH
acetaminophen, pamabrom, pyrilamine maleate tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 59779-879
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
PAMABROM (UNII: UA8U0KJM72) (BROMOTHEOPHYLLINE - UNII:FZG87K1MQ6) PAMABROM25 mg
PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE15 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
CROSPOVIDONE (UNII: 2S7830E561)  
SHELLAC (UNII: 46N107B71O)  
Product Characteristics
ColorPURPLEScoreno score
ShapeOVALSize17mm
FlavorImprint Code 44;679
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 59779-879-271 in 1 CARTON01/13/2015
132 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC: 59779-879-081 in 1 CARTON01/13/2015
224 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34301/13/2015
Labeler - CVS Pharmacy (062312574)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(59779-879)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(59779-879)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(59779-879)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(59779-879)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088PACK(59779-879)

Revised: 2/2019
 
CVS Pharmacy


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