PREMSYN PMS PREMENSTRUAL PAIN RELIEF- acetaminophen and pamabrom and pyrilamine maleate tablet

Premsyn pms Premenstrual Pain Relief by

Drug Labeling and Warnings

Premsyn pms Premenstrual Pain Relief by is a Otc medication manufactured, distributed, or labeled by Focus Consumer Healthcare, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

(in each caplet)

Acetaminophen 500 mg

Pamabrom 25 mg

Pyrilamine maleate 15 mg

PURPOSE

Pain reliever

Antihistamine

Diuretic

INDICATIONS & USAGE

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

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

WARNINGS

Allergy Warning: 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.

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

more than 8 caplets 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

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.

Ask a doctor before use if you have:

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

Ask a doctor or pharmacist before use if you are:

• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers
• When using this product,
• you may get drowsy, avoid alcoholic beverages
• alcohol, sedatives and tranquilizers may increase drowsiness
• use caution when driving or operating machinery
• excitability may occur, especially in children

stop use and ask doctor if:

• Pain gets worse or lasts for more than 10 days
• fever gets worse or lasts for more than 3 days
• new symptoms occur
• redness or swelling is present
• If pregnant or breastfeeding, ask a health professional before use.

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.

Ask a doctor before use if

you have

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

Ask a doctor or pharmacist before use

if you are

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

When using this product

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

Stop use and ask a doctor if

• pain gets worse or lasts for more than 10 days
  
• fever gets worse or lasts for more than 3 days
  
• new symptoms occur
  
• 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 overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.

Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION

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
  
• do not use more than directed (see warnings)

children under 12 years: ask a doctor

INACTIVE INGREDIENT

blue 2, candelilla wax, corn starch, ethylparaben, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregalatinized starch, propylaparaben, red 40, sodium starch glycolate, stearic acid, talc, titanium dioxide

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PREMSYN PMS PREMENSTRUAL PAIN RELIEF 
acetaminophen and pamabrom and pyrilamine maleate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71687-3102
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
CROSPOVIDONE (UNII: 68401960MK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POVIDONE (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	purple (FD & C Red No. 40)	Score	no score
Shape	OVAL	Size	18mm
Flavor		Imprint Code	P
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71687-3102-4	1 in 1 CARTON	10/13/2017
1		40 in 1 BOTTLE, PLASTIC; 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	10/13/2017

Labeler - Focus Consumer Healthcare, LLC (080743737)