NOREL AD- acetaminophen, chlorpheniramine maleate, and phenylephrine hcl tablet, multilayer

Norel AD by

Drug Labeling and Warnings

Norel AD by is a Otc medication manufactured, distributed, or labeled by U.S. PHARMACEUTICAL CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

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

INGREDIENTS AND APPEARANCE

NOREL AD 
acetaminophen, chlorpheniramine maleate, and phenylephrine hcl tablet, multilayer

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52747-475
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	4 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSPOVIDONE (UNII: 2S7830E561)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE K30 (UNII: U725QWY32X)
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Product Characteristics
Color	yellow, white	Score	no score
Shape	TRIANGLE (Arc)	Size	11mm
Flavor		Imprint Code	0425;US
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52747-475-70	20 in 1 BOTTLE; Type 0: Not a Combination Product	04/27/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	04/27/2012

Labeler - US Pharmaceutical Corporation (048318224)