careone sinus congestion and pain

American Sales Company

American Sales Company Sinus Congestion & Pain DayTime NightTime Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Purpose (Day)
• careone sinus congestion and pain Uses (Day)
• Purpose (Night)
• careone sinus congestion and pain Uses (Night)
• Warnings
  • Do not use
  • Ask a doctor before use if you have
  • Ask a doctor or pharmacist before use if you are
  • When using these products
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding,
  • Keep out of reach of children.
• Directions
• Inactive ingredients
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Acetaminophen 325 mg

Phenylephrine HCl 5 mg

Purpose (Day)

Pain reliever

Nasal decongestant

Uses (Day)

• •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

Acetaminophen 325 mg

Chlorpheniramine maleate 2 mg

Phenylephrine HCl 5 mg

Purpose (Night)

Pain reliever

Antihistamine

Nasal decongestant

Uses (Night)

• •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: These products contain acetaminophen. The maximum daily dose of these products 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 these products

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 these products.
• •to make a child sleepy
• •if you have ever had an allergic reaction to these products or any of their ingredients

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 the blood thinning drug warfarin
• •taking sedatives or tranquilizers

When using these products

• •do not exceed recommended dosage

In addition, when using Sinus Congestion & Pain Night:

• •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)

do not take the Day and Night caplets at the same time

do not take more than a total of 10 caplets in 24 hours

DAYTIME

take 2 caplets every 4 hours

swallow whole – do not crush, chew or dissolvetake 2 caplets every 4-6 hours

swallow whole – do not crush, chew or dissolve

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adults and children 12 years and over
children under 12 years	ask a doctor
NIGHTTIME
adults and children 12 years and over
children under 12 years	ask a doctor

Inactive ingredients

DAYTIME acesulfame potassium, carnauba wax, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, flavor, lecithin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide

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

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 and Directions

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

careone sinus congestion and pain Acetaminophen,Phenylephrine HCl, Chlorpheniramine maleate 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:41520-886-56 1 in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date part part341 2011-09-16