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care one sinus

American Sales Company

American Sales Company Sinus Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




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
adults and children 12 years and over
  • take 2 caplets every 4-6 hours
  • swallow whole – do not crush, chew or dissolve
children under 12 years
  • do not use this adult product in children under 12 years of age

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

1-800-719-9260

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
adults and children 12 years and over
  • take 2 caplets every 4 hours
  • swallow whole – do not crush, chew or dissolve
children under 12 years

do not use this adult product in children

under 12 years of age

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

1-800-719-9260

Principal Display Panel

Compare to the Active Ingredients in Tylenol® Sinus Congestion & Pain Day & Night

DAYTIME & NIGHTTIME

CONVENIENCE PACK

SINUS

CONGESTION & PAIN

PAIN RELIEVER - NASAL DECONGESTANT - ANTIHISTAMINE*

See New Warnings Information

Pain Reliever

Nasal Decongestant

Acetaminophen

Phenylephrine HCl

DAYTIME

Nasal Congestion, Sinus Headache, Sinus Pressure

Non Drowsy

Pain Reliever

Nasal Decongestant

*Antihistamine

Acetaminophen

Phenylephrine HCl

Chlorpheniramine Maleate

NIGHTTIME

*Antihistamine in Nighttime only

Headache, Sinus Pressure, Nasal Congestion, Runny Nose

Does Not Contain Pseudoephedrine

care one sinus
Sinus Carton Image 1 Sinus Carton Image 2

care one sinus

Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl KIT

Product Information

Product Type Human otc drug label Item Code (Source) NDC:41520-886
Route of Administration DEA Schedule

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:41520-886-04 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2007-08-22


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Be sure to consult your doctor before taking any medication!
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