MOORE MEDICAL SINUS PAIN AND PRESSURE RELIEF- acetaminophen, phenylephrine hydrochloride tablet

Moore Medical Sinus Pain and Pressure Relief by

Drug Labeling and Warnings

Moore Medical Sinus Pain and Pressure Relief by is a Otc medication manufactured, distributed, or labeled by Moore Medical LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

Acetaminophen 500 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Nasal decongestant

Uses

Temporarily relieves nasal congestion due to

• common cold
• hay fever or other respiratory allergies

Temporarily

• promotes nasal and/or sinus drainage; relieves sinus congestion and pressure
• reduces fever

Temporarily relieves minor aches and pains associated with

• headache
• muscular aches
• minor arthritis pain
• common cold
• toothache
• menstrual cramps

Warnings

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

• more than 8 tablets 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.
• for more than 10 days for pain unless directed by a doctor
• for more than 3 days for fever unless directed by a doctor
• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

• liver disease
• thyroid disease
• diabetes
• high blood pressure
• heart disease
• 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

Stop use and ask a doctor if

• symptoms do not improve within 7 days or are accompanied by a fever
• pain or fever persists or gets worse
• redness or swelling is present
• any new symptoms appear

Do not exceed recommended dosage. If nervousness, dizziness or sleeplessness occur, discontinue use and consult a doctor.

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. 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 use more than directed

Adults and children (12 years and older): Take 2 tablets every 4 to 6 hours. Do not take more than 8 tablets in 24 hours.

Children under 12 years: Do not give this adult strength product to children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

Other information

• store at room temperature 59º-86ºF (15º-30ºC)
• tamper evident sealed packets
• do not use any opened or torn packets
• avoid excessive heat and humidity

Inactive ingredients

corn starch, crospovidone*, FD&C blue #1*, hypromellose*, microcrystalline cellulose, polyethylene glycol*, povidone, sodium starch glycolate*, stearic acid.

*may contain

Questions or comments?

Call 800.234.1464

Moore Medical Sinus PP Label

mooremedical

Supporting Health & Care

Reorder No. 82475

UPN# 0-0607415-82475-9

MooreBrand®

Sinus Pain and Pressure Relief

250 Packets/ 2 Tablets

Acetaminophen 500 mg., Phenylephrine HCl 5 mg.

Non-aspirin pain relief and
Pseudoephedrine-free sinus decongestant

To Reorder:

Call: 1-800-234-1464

Fax: 1-800-944-6667

Online: www.mooremedical.com

INGREDIENTS AND APPEARANCE

MOORE MEDICAL SINUS PAIN AND PRESSURE RELIEF 
acetaminophen, phenylephrine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55670-475
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
CROSPOVIDONE (UNII: 68401960MK)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)

Product Characteristics
Color	white (white)	Score	no score
Shape	ROUND (ROUND)	Size	12mm
Flavor		Imprint Code	AZ;261
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55670-475-13	250 in 1 BOX	12/30/2008
1	NDC: 55670-475-99	2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	12/30/2008

Labeler - Moore Medical LLC (051420107)