MENSTRUAL RELIEF EXTRA STRENGTH- acetaminophen, caffeine, 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:
Better Living Brands, 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: - bloating - headache - water-weight gain - cramps - backache - fatigue - muscle aches
Authorization status:
OTC monograph not final
Authorization number:
21130-990-10

MENSTRUAL RELIEF EXTRA STRENGTH- acetaminophen, caffeine, pyrilamine

maleate tablet

Better Living Brands, 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.

----------

Signature Care 44-390

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:

bloating

headache

water-weight gain

cramps

backache

fatigue

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

difficulty in urination due to enlargement of the prostate gland

liver disease

glaucoma

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

avoid alcoholic beverages

excitability may occur, especially in children

be careful when driving a motor vehicle or operating machinery

alcohol, sedatives, and tranquilizers may increase drowsiness

you may get drowsy

limit the use of caffeine-containing medications, foods, or beverages while taking this product

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

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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222)

right away. Prompt 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 over:

take 2 caplets with water

repeat every 6 hours, as needed

do not exceed 6 caplets per day

children under 12 years: ask a doctor

Other information

see end flap for expiration date and lot number

store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Inactive ingredients

corn starch, croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, microcrystalline

cellulose, polydextrose, polyethylene glycol, povidone, silicon dioxide, stearic acid, titanium dioxide,

triacetin

Questions or comments?

1-800-426-9391

Principal Display Panel

Signature

care

Quality Guaranteed

COMPARE TO

Midol

Complete

active ingredients*

NDC 21130-990-10

EXTRA STRENGTH

Menstrual Relief

ACETAMINOPHEN 500 mg

Caffeine 60 mg

Pyrilamine maleate 15 mg

Pain Reliever / Diuretic / Antihistamine

Relief of:

Cramps Bloating

Fatigue Backache

Headache

Actual Size

40 CAPLETS

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by Bayer HealthCare LLC,

distributors of Midol

Complete.

50844 REV0517D39010

DISTRIBUTED BY

BETTER LIVING BRANDS LLC

P.O. BOX 99, PLEASANTON, CA 94566-0009

1-888-723-3929

www.betterlivingbrandsLLC.com

OUR PROMISE

QUALITY & SATISFACTION

100% GUARANTEED

OR YOUR MONEY BACK.

Sig nature care 4 4 -390

MENSTRUAL RELIEF EXTRA STRENGTH

acetaminophen, caffeine, pyrilamine maleate tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:21130 -9 9 0

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

STARCH, CO RN (UNII: O8 232NY3SJ)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

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

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

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

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

PO LYDEXTRO SE (UNII: VH2XOU12IE)

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

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

STEARIC ACID (UNII: 4ELV7Z6 5AP)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

TRIACETIN (UNII: XHX3C3X6 73)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

Product Characteristics

Color

WHITE

S core

no sco re

S hap e

OVAL

S iz e

17mm

Flavor

Imprint Code

44;39 0

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:21130 -9 9 0 -10

1 in 1 CARTON

0 4/29 /20 0 2

1

40 in 1 BOTTLE; 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 4/29 /20 0 2

Better Living Brands, LLC

Labeler -

Better Living Brands, LLC (009137209)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

0 38 15446 4

PACK(21130 -9 9 0 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 9 4

MANUFACTURE(21130 -9 9 0 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 37

PACK(21130 -9 9 0 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

9 6 76 26 30 5

PACK(21130 -9 9 0 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 6 8 7340 8 8

PACK(21130 -9 9 0 )

Revised: 10/2019

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