MENSTRUAL PAIN RELIEF MAXIMUM STRENGTH- acetaminophen, pamabrom, pyrilamine maleate tablet, film coated
CHAIN DRUG MARKETING ASSOCIATION INC

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.

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Quality Choice 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 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
a breathing problem such as emphysema or chronic bronchitis
liver disease
glaucoma

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers
taking the blood thinning drug warfarin

When using this product

drowsiness may occur
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 directed
adults and children 12 years and over:
- take 2 caplets with water every 6 hours as needed
- do not exceed 6 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 15º-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

QC
QUALITY®
CHOICE

NDC 63868-961-20

Compare to the
Active Ingredients in
Maximum Strength
Pamprin® Multi-Symptom*

Maximum Strength

Menstrual Pain Relief

Multi-Symptom
Acetaminophen - Pain Reliever
Pamabrom - Diuretic
Pyrilamine Maleate - Antihistamine
Relieves: Cramps, Irritability, Headache, Bloating, Backache

20 Caplets

actual size

*This product is not manufactured or distributed by Focus Consumer Healthcare, LLC, owner of the registered trademark Maximum Strength Pamprin® Multi-Symptom.

50844 REV0718A67909

QC
100%
SATISFACTION
GUARANTEED

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

44-679

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63868-961
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
PAMABROM (UNII: UA8U0KJM72) (BROMOTHEOPHYLLINE - UNII:FZG87K1MQ6)	PAMABROM	25 mg
PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL)	PYRILAMINE MALEATE	15 mg

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CROSPOVIDONE (UNII: 2S7830E561)
FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SHELLAC (UNII: 46N107B71O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	purple	Score	no score
Shape	OVAL	Size	17mm
Flavor		Imprint Code	44;679
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63868-961-20	1 in 1 CARTON	01/13/2015
1		20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	01/13/2015

Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(63868-961)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	pack(63868-961)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	manufacture(63868-961)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	pack(63868-961)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(63868-961)

Revised: 4/2023

Document Id: 6672ec59-20c3-4151-9478-44d464dc0267

Set id: 12a04f45-64bd-4953-9564-79020bc08e2e

Version: 10

Effective Time: 20230411

CHAIN DRUG MARKETING ASSOCIATION INC