MENSTRUAL RELIEF- acetaminophen, caffeine and pyrilamine maleate tablet

Menstrual Relief by

Drug Labeling and Warnings

Menstrual Relief by is a Otc medication manufactured, distributed, or labeled by TOP CARE (Topco Associates LLC). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each caplet)

Acetaminophen 500 mg

Caffeine 60 mg

Pyrilamine maleate 15 mg

Purpose

Pain reliever

Diuretic

Antihistamine

Uses

• for the temporary relief of these symptoms associated with menstrual periods
  • cramps
  • bloating
  • fatigue
  • backache
  • water-weight gain
  • headache
  • muscle aches

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.
• if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

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

When using this product

• drowsiness may occur
• avoid alcoholic drinks
• excitability may occur, especially in children
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• limit the use of caffeine-containing medications, foods, or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat. The recommended dose of this product contains about as much caffeine as a cup of coffee.

Stop use and ask a doctor if

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

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 overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical 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 older
  • take 2 caplets with water
  • repeat every 6 hours, as needed 
  • do not take more than 6 caplets in 24 hours
• children under 12 years: consult a doctor

Other information

• store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86º F)

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, povidone, pregelatinized starch, stearic acid, titanium dioxide

Questions or comments?

Call toll free 1-888-423-0139

Principal Display Panel

COMPARE TO MIDOL® COMPLETE ACTIVE INGREDIENTS*

MAXIMUM STRENGTH SUPPORTING THE FIGHT AGAINST BREAST CANCER†

Menstrual Relief

ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE

PAIN RELIEVER DIURETIC ANTIHISTAMINE

MULTI-SYMPTOM RELIEF OF:

• Cramps
• Bloating
• Fatigue
• Backache 
• Headache

CAPLETS

*This product is not manufactured or distributed by Bayer HealthCare LLC, distributor of Midol® Complete.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY: TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007 ©TOPCO

QUESTIONS? 1-888-423-0139

topcare@topcare.com    

Product Label

TOPCARE HEALTH Menstrual Relief

INGREDIENTS AND APPEARANCE

MENSTRUAL RELIEF 
acetaminophen, caffeine and pyrilamine maleate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-187
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	60 mg
PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL)	PYRILAMINE MALEATE	15 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CROSPOVIDONE (UNII: 2S7830E561)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	CAPSULE	Size	17mm
Flavor		Imprint Code	TCL347
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-187-24	24 in 1 CARTON	03/31/2014
1		1 in 1 BLISTER PACK; 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	03/31/2014

Labeler - TOP CARE (Topco Associates LLC) (006935977)