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

PMS Relief by

Drug Labeling and Warnings

PMS Relief by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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
CVS.com® 1-800-SHOP  CVS

V-11112

CVS®Quality
Money Back Guarantee

CVS 44-679

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-879
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
PAMABROM (UNII: UA8U0KJM72) (BROMOTHEOPHYLLINE - UNII:FZG87K1MQ6)	PAMABROM	25 mg
PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL)	PYRILAMINE MALEATE	15 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	PURPLE	Score	no score
Shape	OVAL	Size	17mm
Flavor		Imprint Code	44;679
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-879-27	1 in 1 CARTON	01/13/2015
1		32 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 59779-879-08	1 in 1 CARTON	01/13/2015
2		24 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	01/13/2015

Labeler - CVS Pharmacy (062312574)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(59779-879)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(59779-879)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(59779-879)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(59779-879)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(59779-879)