Pamprin Multi-Symptom Maximum Strength (Acetaminophen, Pamabrom, Pyrilamine Maleate) Tablet [Focus Consumer Healthcare, Llc] -

PAMPRIN MULTI-SYMPTOM MAXIMUM STRENGTH (ACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATE) TABLET [FOCUS CONSUMER HEALTHCARE, LLC]
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NDC	71687-3003-1, 71687-3003-4
Set ID	60b3286d-5698-df50-e053-2991aa0afbe2
Category	HUMAN OTC DRUG LABEL
Packager	Focus Consumer Healthcare, LLC
Generic Name
Product Class
Product Number
Application Number	PART343

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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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
CANDELILLA WAX (UNII: WL0328HX19)
STARCH, CORN (UNII: O8232NY3SJ)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	06/01/2016

Labeler - Focus Consumer Healthcare, LLC (080743737)

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Medic

PAMPRIN MULTI-SYMPTOM MAXIMUM STRENGTH (ACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATE) TABLET [FOCUS CONSUMER HEALTHCARE, LLC]

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