FDA Label for Moore Medical Sinus Pain And Pressure Relief
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- TEMPORARILY RELIEVES NASAL CONGESTION DUE TO
- TEMPORARILY
- TEMPORARILY RELIEVES MINOR ACHES AND PAINS ASSOCIATED WITH
- LIVER WARNING:
- ALLERGY ALERT: ACETAMINOPHEN MAY CAUSE SEVERE SKIN REACTIONS.
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS:
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- MOORE MEDICAL SINUS PAIN AND PRESSURE RELIEF LABEL
Moore Medical Sinus Pain And Pressure Relief Product Label
The following document was submitted to the FDA by the labeler of this product Moore Medical Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Do not exceed recommended dosage. If nervousness, dizziness or sleeplessness occur, discontinue use and consult a doctor.
Active Ingredient (In Each Tablet)
Acetaminophen 500 mg
Phenylephrine HCl 5 mg
Purpose
Pain reliever/fever reducer
Nasal decongestant
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
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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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 59°-86°F (15°-30°C)
- 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?
1.800.234.1464
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 decongestant
To Reorder:
Call: 1.800.234.1464
Fax: 1.800.944.6667
Online: www.mooremedical.com
* Please review the disclaimer below.