Label: MOORE MEDICAL SINUS PAIN AND PRESSURE RELIEF- acetaminophen, phenylephrine hydrochloride tablet
- NDC Code(s): 55670-150-13
- Packager: Moore Medical LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated June 6, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
- Purpose
- Uses
-
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
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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
- Inactive ingredients
- Questions or comments?
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Moore Medical Sinus Pain and Pressure Relief Label
mooremedical
Supporting Health & Care
Reorder No. 82475
UPN# 0-0607415-82475-9
MooreBrand®
Sinus Pain and Pressure Relief
250 Packets/ 2 Tablets
Acetaminophen 500mg., Phenylephrine HCl 5mg.
Non-aspirin pain relief and
Pseudoephedrine-free sinus decongestantTo Reorder:
Call: 1.800.234.1464
Fax: 1.800.944.6667
Online: www.mooremedical.com
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INGREDIENTS AND APPEARANCE
MOORE MEDICAL SINUS PAIN AND PRESSURE RELIEF
acetaminophen, phenylephrine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55670-150 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) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color blue (blue) Score no score Shape ROUND (ROUND) Size 12mm Flavor Imprint Code FR;33 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55670-150-13 250 in 1 BOX 12/30/2008 07/31/2024 1 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 07/31/2024 Labeler - Moore Medical LLC (051420107) Registrant - Unifirst First Aid Corporation (832947092)