TYLENOL SINUS CONGESTION AND PAIN DAYTIME description, usages, side effects, indications, overdosage, supplying and lots more!

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TYLENOL SINUS CONGESTION AND PAIN DAYTIME

McNeil Consumer Healthcare Div. McNeil-PPC, Inc

TYLENOL SINUS CONGESTION & PAIN


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active ingredients (in each caplet) Purpose
Acetaminophen 325 mg Pain reliever/fever reducer
Phenylephrine HCl 5 mg Nasal decongestant

TYLENOL SINUS CONGESTION AND PAIN DAYTIME Uses

  • temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:
    • headache
    • sinus congestion and pressure
    • nasal congestion
    • minor aches and pains
  • helps decongest sinus openings and passages
  • promotes sinus drainage
  • helps clear nasal passages
  • temporarily reduces fever

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.
  • 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
  • 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 exceed recommended dose

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.

Overdose warning

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

adults and children 12 years and over
  • take 2 caplets every 4 hours
  • swallow whole; do not crush, chew or dissolve
  • do not take more than 10 caplets in 24 hours
children under 12 years ask a doctor

TYLENOL SINUS CONGESTION AND PAIN DAYTIME Other information

  • store between 20-25°C (68-77°F)
  • do not use if carton is opened or if blister unit is broken

Inactive ingredients

anhydrous citric acid, carnauba wax, corn starch, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, flavors, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, potassium sorbate, powdered cellulose, pregelatinized starch, sodium benzoate, sodium citrate, sodium starch glycolate, sucralose, titanium dioxide

Questions or comments?

call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL

NDC 50580-594-24

See New Warnings Information & Directions

TYLENOL®
SINUS
CONGESTION & PAIN

For Adults

Acetaminophen, Phenylephrine HCl
Pain Reliever/Fever Reducer, Nasal Decongestant

DAYTIME
Non-Drowsy

Sinus Headache
Nasal Congestion
Sinus Pressure

24 CAPLETS

TYLENOL SINUS CONGESTION AND PAIN DAYTIME

TYLENOL SINUS CONGESTION AND PAIN DAYTIME

Acetaminophen and Phenylephrine hydrochloride TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:50580-594
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS CITRIC ACID
carnauba wax
STARCH, CORN
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C RED NO. 40
ALUMINUM OXIDE
HYPROMELLOSES
MAGNESIUM STEARATE
cellulose, microcrystalline
POLYETHYLENE GLYCOLS
polysorbate 80
POTASSIUM SORBATE
POWDERED CELLULOSE
SODIUM BENZOATE
SODIUM CITRATE
Sucralose
titanium dioxide
SODIUM STARCH GLYCOLATE TYPE A POTATO

Product Characteristics

Color Size Imprint Code Shape
GREEN (Light Green) 18 mm TYLENOL;1080 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 12 in 1 BLISTER PACK
2 12 in 1 BLISTER PACK
3 NDC:50580-594-72 6 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2012-07-01


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Be sure to consult your doctor before taking any medication!
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