MIDOL COMPLETE- acetaminophen, caffeine, and pyrilamine maleate tablet

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

এখন এটা কিনুন

সক্রিয় উপাদান:
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E), PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL)
থেকে পাওয়া:
R J General Corporation
INN (International Name):
ACETAMINOPHEN
রচনা:
ACETAMINOPHEN 500 mg
প্রশাসন রুট:
ORAL
প্রেসক্রিপশন টাইপ:
OTC DRUG
থেরাপিউটিক ইঙ্গিত:
for the temporary relief of these symptoms associated with menstrual periods: - cramps - bloating - water-weight gain - headache - backache - muscle aches - fatigue
অনুমোদন অবস্থা:
OTC monograph not final
অনুমোদন সংখ্যা:
70264-012-01

MIDOL COMPLETE- acetaminophen, caffeine, and pyrilamine maleate tablet

R J General Corporation

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.

----------

MIDOL COMPLETE

Drug Facts

Active ingredients (in each caplet)

Purpose

Acetaminophen 500 mg

Pain reliever

Caffeine 60 mg

Diuretic

Pyrilamine maleate 15 mg

Antihistamine

Us es

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

cramps

bloating

water-weight gain

headache

backache

muscle aches

fatigue

Warnings

Liver warning

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

more than 6 caplets in 24 hours, which is the maximum daily amount for this product

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.

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

®

you may get drowsy

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 lasts more than 3 days

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

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 exceed 6 caplets per day

children under 12 years: consult a doctor

Other information

store at room temperature

Inactive ingredients

carnauba wax, croscarmellose sodium, FD&C blue #2 aluminum lake, hypromellose, magnesium

stearate, microcrystalline cellulose, pregelatinized starch, propylene glycol, shellac, titanium dioxide,

triacetin

Questions or comments?

1-800-331-4536 (Mon-Fri 9AM - 5PM EST) or www.midol.com

PRINCIPAL DISPLAY PANEL - 100 Caplet Pouch Carton

Midol

Complete

Acetaminophen/Caffeine/Pyrilamine Maleate

Pain Reliever/Diuretic/Antihistamine

MAXIMUM STRENGTH

MULTI-SYMPTOM

®

RELIEF OF

CRAMPS, BLOATING

FATIGUE, BACKACHE

& HEADACHE

50 POUCHES of 2 CAPLETS

MIDOL COMPLETE

acetaminophen, caffeine, and pyrilamine maleate tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:70 26 4-0 12(NDC:0 28 0 -8 0 0 5)

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

FD&C BLUE NO . 2 (UNII: L0 6 K8 R7DQK)

HYPRO MELLO SE, UNSPECIFIED (UNII: 3NXW29 V3WO)

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

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

TRIACETIN (UNII: XHX3C3X6 73)

R J General Corporation

CARNAUBA WAX (UNII: R12CBM0 EIZ)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

SHELLAC (UNII: 46 N10 7B71O)

Product Characteristics

Color

WHITE

S core

no sco re

S hap e

OVAL

S iz e

17mm

Flavor

Imprint Code

MIDOL

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:70 26 4-0 12-0 1

50 in 1 CARTON

0 2/10 /20 14

1

2 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

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 2/10 /20 14

Labeler -

R J General Corporation (122542830)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

R J General Co rpo ratio n

1225428 30

REPACK(70 26 4-0 12)

Revised: 8/2018

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