Topcare Sinus Congestion and Pain

Topco Associates LLC

Topco Sinus Congestion and Pain Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each caplet) - Nighttime
• Purpose - Nighttime
• Topcare Sinus Congestion and Pain Uses - Nighttime
• Warnings - Nighttime
  • 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 - Nighttime
• Inactive ingredients - Nighttime
• Questions or comments? - Nighttime
• Active ingredient (in each caplet) - Daytime
• Purpose - Daytime
• Topcare Sinus Congestion and Pain Uses - Daytime
• Warnings - Daytime
  • 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 - Daytime
• Inactive ingredients - Daytime
• Questions or comments? - Daytime
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredient (in each caplet) - Nighttime

Acetaminophen 325 mg

Chlorpheniramine maleate 2 mg

Phenylephrine HCl 5 mg

Purpose - Nighttime

Pain reliever

Antihistamine

Nasal decongestant

Uses - Nighttime

• 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 - Nighttime

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

• more than 12 caplets 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

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

Ask a doctor before use if you have

• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• 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 sedatives or tranquilizers
• taking the blood thinning drug warfarin

When using this product

• do not use more than directed
• 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

• you get nervous, dizzy or sleepless
• 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 - Nighttime

• do not take more than directed (see Liver warning)
• do not take the Day and Night caplets at the same time
• do not take more than a total of 12 caplets in 24 hours

Inactive ingredients - Nighttime

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

Questions or comments? - Nighttime

1-888-423-0139

Active ingredient (in each caplet) - Daytime

Acetaminophen 325 mg

Phenylephrine HCl 5 mg

Purpose - Daytime

Pain reliever

Nasal decongestant

Uses - Daytime

• for the temporary relief of:
• headache
• sinus congestion and pressure
• nasal congestion
• minor aches and pains
• helps decongest sinus openings and passages
• promotes sinus drainage
• helps clear nasal passages

Warnings - Daytime

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

• more than 12 caplets 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

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
• trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

When using this product

do not use more than directed

Stop use and ask a doctor if

• you get nervous, dizzy or sleepless
• 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 - Daytime

• do not take more than directed (see Liver warning)
• do not take the Day and Night caplets at the same time
• do not take more than a total of 12 caplets in 24 hours

Inactive ingredients - Daytime

acesulfame potassium, carnauba wax, crospovidone, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, flavor, lecithin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, starch, stearic acid, talc, titanium dioxide

Questions or comments? - Daytime

1-888-423-0139

Principal Display Panel

See New Warnings Information

Daytime & Nighttime Convenience Pack

Sinus

Congestion & Pain

Pain Reliever/Nasal Decongestant/*Antihistamine

Day

Non-Drowsy

Contains 2 Medicines:

Headache/Acetaminophen

Sinus Pressure/Nasal Congestion – Phenylephrine HCl

Night

*Antihistamine in Nighttime Only

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 Day & Night active ingredients