PREMSYN PMS PREMENSTRUAL SYNDROME RELIEF- acetaminophen and pamabrom and pyrilamine maleate tablet
Chattem, 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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Premsyn pms Premenstrual Syndrome Relief

Drug Facts

Active ingredients

(in each caplet)

Acetaminophen 500 mg

Purposes

Pain reliever

Active ingredients

(in each caplet)

Pamabrom 25 mg

Purposes

Diuretic

Active ingredients

(in each caplet)

Pyrilamine maleate 15 mg

Purposes

Antihistamine

Uses

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

cramps
headache
bloating
backache
water-weight gain
muscular aches
irritability

Warnings

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 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.

Directions

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 ingredients

crospovidone, magnesium stearate, povidone, pregelatinized starch, sodium starch glycolate, stearic acid (224-186)

PRINCIPAL DISPLAY PANEL

MAXIMUM STRENGTH
Prēmsyn
pms®
Premenstrual Syndrome Relief of
Tension Bloating
Irritability
Aspirin and Caffeine Free with Acetaminophen,
Pamabrom and Pyrilamine Maleate 20 Caplets
See new warnings information – Acetaminophen

PRINCIPAL DISPLAY PANEL
Premsyn pms Premenstrual Syndrome Relief

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41167-3102
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
CROSPOVIDONE (UNII: 2S7830E561)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POVIDONE (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	18mm
Flavor		Imprint Code	PREMSYN;PMS
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41167-3102-1	1 in 1 CARTON	05/01/2010	02/28/2019
1		20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC:41167-3102-3	1 in 1 CARTON	05/01/2010	02/28/2019
2		40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part343	05/01/2010	02/28/2019

Labeler - Chattem, Inc. (003336013)

Revised: 2/2019

Document Id: 1c29388b-a57a-4af7-b9c7-a16cc201fe64

Set id: ce280f7d-ca22-473d-b276-de44933e7957

Version: 11

Effective Time: 20190228

Chattem, Inc.