PAMPRIN MULTI-SYMPTOM MAXIMUM STRENGTH- acetaminophen, pamabrom, pyrilamine maleate tablet

Pamprin Multi-Symptom by

Drug Labeling and Warnings

Pamprin Multi-Symptom by is a Otc medication manufactured, distributed, or labeled by Focus Consumer Healthcare, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each caplet)

Acetaminophen 500 mg
Pamabrom 25 mg
Pyrilamine maleate 15 mg

PURPOSE

Purposes

Pain reliever
Diuretic
Antihistamine

INDICATIONS & USAGE

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

cramps

headache

bloating

backache
water-weight gain

muscular aches

irritability

WARNINGS

Allergy warning: 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.

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 8 caplets 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

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.

Ask a doctor before use if you have liver disease glaucoma a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland

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 alcohol, sedatives and tranquilizers may increase drowsiness use caution when driving or operating machinery excitability may occur, especially in children

Stop use and ask a doctor if

pain gets worse or lasts for more than 10 days
fever gets worse or lasts for more than 3 days
new symptoms occur
redness or swelling is present

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

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

do not use more than directed (see warnings)

children under 12 years: ask a doctor

INACTIVE INGREDIENT

blue 2, candelilla wax, corn starch, ethylparaben, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylparaben, red 40, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions or Comments?

www.pamprin.com

SPL UNCLASSIFIED SECTION

IF IMPRINTED INNER SEAL ON BOTTLE IS BROKEN OR MISSING, DO NOT USE.

Easy-open bottle with child-resisitant packaging. Purchase only if carton end flaps are sealed.

Distributed by:

Focus Consumer Healthcare, LLC

801 Broad Street, Chattanooga, TN 37402

Made in Canada

©2017 Focus Consumer Healthcare, LLC

www.pamprin.com

PRINCIPAL DISPLAY PANEL

Maximum Strength

Pamprin Multi-Symptom

for complete Relief of Cramps Headache Backache Irritability Bloating

Mentrual Pain Relief

Aspirin-free and Caffeine-free with Acetaminophen, Pamabrom and Pyrilamine Maleate

20 Caplets

INGREDIENTS AND APPEARANCE

PAMPRIN MULTI-SYMPTOM  MAXIMUM STRENGTH
acetaminophen, pamabrom, pyrilamine maleate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71687-3003
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
ETHYLPARABEN (UNII: 14255EXE39)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
CANDELILLA WAX (UNII: WL0328HX19)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	purple	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code	P
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71687-3003-1	1 in 1 CARTON	06/01/2016
1		20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 71687-3003-4	1 in 1 CARTON	06/01/2016
2		40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	06/01/2016

Labeler - Focus Consumer Healthcare, LLC (080743737)