MENSTRUAL RELIEF- acetaminophen, caffeine and pyrilamine maleate tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E), PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL)
Available from:
TOP CARE (Topco Associates LLC)
INN (International Name):
ACETAMINOPHEN
Composition:
ACETAMINOPHEN 500 mg
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever Diuretic Antihistamine - for the temporary relief of these symptoms associated with menstrual periods cramps bloating fatigue backache water-weight gain headache muscle aches - cramps - bloating - fatigue - backache - water-weight gain - headache - muscle aches
Authorization status:
OTC monograph not final
Authorization number:
36800-187-24

MENSTRUAL RELIEF- acetaminophen, caffeine and pyrilamine maleate tablet

TOP CARE (Topco Associates LLC)

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.

----------

Drug Facts

Active ingredients (in each caplet)

Acetaminophen 500 mg

Caffeine 60 mg

Pyrilamine maleate 15 mg

Purpos e

Pain reliever

Diuretic

Antihistamine

Us es

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

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

SUPPORTING THE FIGHT AGAINST BREAST CANCER†

TOPCARE HEALTH Menstrual Relief

MENSTRUAL RELIEF

acetaminophen, caffeine and pyrilamine maleate tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:36 8 0 0 -18 7

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D)

ACETAMINOPHEN

50 0 mg

CAFFEINE (UNII: 3G6 A5W338 E) (CAFFEINE - UNII:3G6 A5W338 E)

CAFFEINE

6 0 mg

PYRILAMINE MALEATE (UNII: R35D29 L3ZA) (PYRILAMINE - UNII:HPE317O9 TL)

PYRILAMINE MALEATE

15 mg

Inactive Ingredients

Ingredient Name

Stre ng th

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

CRO SPO VIDO NE (UNII: 2S78 30 E56 1)

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

MINERAL O IL (UNII: T5L8 T28 FGP)

PO VIDO NE (UNII: FZ9 8 9 GH9 4E)

STARCH, CO RN (UNII: O8 232NY3SJ)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product Characteristics

Color

WHITE

S core

no sco re

S hap e

CAPSULE

S iz e

17mm

Flavor

Imprint Code

TCL347

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:36 8 0 0 -18 7-24

24 in 1 CARTON

0 3/31/20 14

1

1 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

TOP CARE (Topco Associates LLC)

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH NOT FINAL part343

0 3/31/20 14

Labeler -

T OP CARE (T opco Associates LLC) (006935977)

Revised: 10/2019

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