Topcare Sinus Congestion and Pain

Topco Associates LLC

Topco Sinus Congestion & Pain Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each caplet)
• Purpose
• Topcare Sinus Congestion and Pain 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 reach of children.
• Directions
• Topcare Sinus Congestion and Pain Other information
• Inactive ingredients
• Questions or comments?
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredient (in each caplet)

Acetaminophen 325 mg

Chlorpheniramine maleate 2 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever

Antihistamine

Nasal decongestant

Topcare Sinus Congestion and Pain Uses

• •for the temporary relief of:
• •headache
• •sinus congestion and pressure
• •nasal congestion
• •runny nose and sneezing
• •minor aches and pains
• •reduces swelling of nasal passages
• •helps decongest sinus openings and passages

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take

• •more than 4,000 mg of acetaminophen in 24 hours
• •with other drugs containing acetaminophen
• •3 or more alcoholic drinks every day while using this product

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.
• •to make a child sleepy
• •if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

• •liver disease
• •heart disease
• •high blood pressure
• •diabetes
• •thyroid disease
• •trouble urinating due to an enlarged prostate gland
• •a breathing problem such as emphysema or chronic bronchitis
• •glaucoma

Ask a doctor or pharmacist before use if you are

• •taking the blood thinning drug warfarin
• •taking sedatives or tranquilizers

When using this product

• •do not exceed recommended dosage
• •excitability may occur, especially in children
• •drowsiness may occur
• •alcohol, sedatives, and tranquilizers may increase drowsiness
• •avoid alcoholic drinks
• •be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

• •nervousness, dizziness, or sleeplessness occur
• •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
• •new symptoms occur

These could be signs of a serious condition.

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. (1-800-222-1222) 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 Liver warning)

adults and children 12 years and overtake 2 caplets every 4-6 hours

swallow whole – do not crush, chew or dissolve

do not take more than 10 caplets in 24 hourschildren under 12 yearsask a doctor

•

•

•

Topcare Sinus Congestion and Pain Other information

• •store at 20°-25°C (68°-77°F)

Inactive ingredients

acesulfame potassium, carnauba wax, flavor, iron oxide yellow, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide

Questions or comments?

1-888-423-0139

Principal Display Panel

SEE NEW WARNINGS AND DIRECTIONS

NIGHTTIME

Sinus

Congestion & Pain

PAIN RELIEVER / NASAL DECONGESTANT

ANTIHISTAMINE

Contains 3 Medicines:

Headache / Acetaminophen

Sinus Pressure/Nasal Congestion / Phenylephrine HCl

Runny Nose – Chlorpheniramine Maleate

Instant Cooling Sensation

Cool Ice®

actual size

COMPARE TO TYLENOL® SINUS CONGESTION & PAIN NIGHTTIME active ingredients

Topcare Sinus Congestion and Pain Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl TABLET Product Information Product Type Human otc drug label Item Code (Source) NDC:36800-935 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN ACETAMINOPHEN 325 mg Chlorpheniramine Maleate CHLORPHENIRAMINE 2 mg Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM carnauba wax FERRIC OXIDE YELLOW cellulose, microcrystalline POLYETHYLENE GLYCOLS POLYVINYL ALCOHOL POVIDONES STEARIC ACID talc titanium dioxide Product Characteristics Color Size Imprint Code Shape WHITE (off white) 16 mm L476 CAPSULE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 12 in 1 BLISTER PACK 2 NDC:36800-935-62 2 in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date part part341 2009-03-23