MENSTRUAL RELIEF MAXIMUM STRENGTH- acetaminophen, pamabrom, pyrilamine maleate tablet, film coated

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

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Active ingredient:
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), PAMABROM (UNII: UA8U0KJM72) (BROMOTHEOPHYLLINE - UNII:FZG87K1MQ6), PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL)
Available from:
ARMY AND AIR FORCE EXCHANGE SERVICE
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever Diuretic Antihistamine for the temporary relief of these symptoms associated with menstrual periods: - headache - bloating - cramps - backache - muscular aches - irritability - water-weight gain
Authorization status:
OTC monograph not final
Authorization number:
55301-679-27

MENSTRUAL RELIEF MAXIMUM STRENGTH- acetaminophen, pamabrom, pyrilamine

maleate tablet, film coated

ARMY AND AIR FORCE EXCHANGE SERVICE

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.

----------

Exchange Select 44-679

Active ingredients (in each caplet)

Acetaminophen 500 mg

Pamabrom 25 mg

Pyrilamine maleate 15 mg

Purpose

Pain reliever

Diuretic

Antihistamine

Uses

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

headache

bloating

cramps

backache

muscular aches

irritability

water-weight gain

Warnings

Liver warning: This product contain acetaminophen. Severe liver damage may occur if you take:

more than 4,000 mg 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

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

a breathing problem such as emphysema or chronic bronchitis

glaucoma

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

excitability may occur, especially in children

alcohol, sedatives and tranquilizers may increase drowsiness

use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

pain gets worse or lasts more than 10 days

fever gets worse or lasts more than 3 days

new symptoms occur

redness or swelling is present

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 every 6 hours as needed

do not exceed 8 caplets in a 24 hour period or as directed by a doctor

children under 12 years: ask a doctor

Other information

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

see end flap for expiration date and lot number

Inactive ingredients

corn starch, croscarmellose sodium, crospovidone, FD&C blue #2 aluminum lake, FD&C red #40

aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol,

povidone, shellac wax, silicon dioxide, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-426-9391

Principal display panel

exchange s elect

Compare To The Active Ingredients of Maximum Strength Pamprin® Multi-Symptom*

Aspirin Free

Caffeine Free

Maximum Strength

Menstrual Relief

Acetaminophen, Pamabrom, Pyrilamine maleate

Pain reliever / Diuretic / Antihistamine

Multi-Symptom Relief of:

Cramps, Bloating, Irritability,

Headache & Backache

32 Caplets

quality value

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS

BROKEN OR MISSING

*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark

Maximum Strength Pamprin® Multi-Symptom.

50844 REV1116A67927

"SATISFACTION GUARANTEED OR YOUR MONEY BACK"

Manufactured For Your Military Exchanges

Distributed by: LNK International, Inc.

Hauppauge, NY 11788

1-800-426-9391

Exchang e Select 4 4 -679

MENSTRUAL RELIEF MAXIMUM STRENGTH

acetaminophen, pamabrom, pyrilamine maleate tablet, film coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:5530 1-6 79

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

PAMABRO M (UNII: UA8 U0 KJM72) (BROMOTHEOPHYLLINE - UNII:FZG8 7K1MQ6 )

PAMABROM

25 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 )

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

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

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

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

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

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

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

TALC (UNII: 7SEV7J4R1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

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

PO LYVINYL ALCO HO L, UNSPECIFIED (UNII: 532B59 J9 9 0 )

SHELLAC (UNII: 46 N10 7B71O)

Product Characteristics

Color

PURPLE

S core

no sco re

S hap e

OVAL

S iz e

17mm

Flavor

Imprint Code

44;6 79

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:5530 1-6 79 -27

1 in 1 CARTON

0 1/13/20 15

1

32 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 1/13/20 15

Labeler -

ARMY AND AIR FORCE EXCHANGE SERVICE (001695568)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 37

PACK(5530 1-6 79 )

ARMY AND AIR FORCE EXCHANGE SERVICE

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

9 6 76 26 30 5

PACK(5530 1-6 79 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 6 8 7340 8 8

PACK(5530 1-6 79 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

0 38 15446 4

PACK(5530 1-6 79 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 9 4

MANUFACTURE(5530 1-6 79 )

Revised: 4/2020

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