FDA Label for Norel Ad
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (PER TABLET)
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST FEEDING
- KEEP OUT OF THE REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS
- PRINCIPAL DISPLAY PANEL
Norel Ad Product Label
The following document was submitted to the FDA by the labeler of this product U.s. Pharmaceutical Corporation. 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.
Active Ingredients (Per Tablet)
Acetaminophen 325 mg
Chlorpheniramine Maleate 4 mg
Phenylephrine HCl 10 mg
Purpose
Pain reliever
Antihistamine
Nasal decongestant
Uses
Temporarily relieves these symptoms due to the common cold or flu
- nasal congestion
- runny nose
- minor aches and pains
- headache
- sore throat
- sneezing
- itchy, watery eyes
- itching of the nose or throat
- sinus congestion and pressure
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
- adult takes more than 6 tablets in 24 hours, which is the maximum daily amount
- child takes more than 5 doses in 24 hours
- taken with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks every day while using this product
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, speak with a healthcare provider.
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.
- 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
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
Ask A Doctor Or Pharmacist Before Use If You Are
- taking the blood thinning drug warfarin
- taking any other nasal decongestant or stimulant
- taking sedatives or tranquilizers
When Using This Product
- do not exceed recommended dosage
- drowsiness may occur
- avoid alcoholic beverages
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
Stop Use And Ask A Doctor If
- pain or nasal congestion gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- you get nervous, dizzy, or sleepless
- new symptoms occur
If Pregnant Or Breast Feeding
- ask a health professional before use
Keep Out Of The Reach Of Children.
Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact 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
- do not take more than directed (see overdose warning)
- adults and children 12 years of age and over: take 1 tablet every 4 hours, while symptoms persist
- do not take more than 6 tablets in 24 hours, unless directed by a doctor
- children under 12 years of age: ask a doctor
Other Information
store at 20°-25°C (68°-77°F)
Overdose Warning: Keep this and all medication out of the reach of children. In case of accidental overdose, seek medical help or contact a Poison Control Center immediately.
Inactive Ingredients
Colloidal Silicon Dioxide, Crospovidone Polyplasdone, Magnesium Stearate (vegetable base), Microcrystalline Cellulose, Povidone K-30, Pregelatinized Starch, Stearic Acid, D&C Yellow #10, FD&C Yellow #6.
Questions Or Comments
Please visit www.uspco.com or contact us at US Pharmaceutical Corporation, P.O. Box 360465, Decatur, GA 30036
Principal Display Panel
Figure 1: Norel ® AD container label
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