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sinus congestion and pain

Meijer Distribution Inc

Meijer Distribution, Inc. Pain & Sinus Congestion Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each caplet)

Acetaminophen 325 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever

Nasal decongestant

sinus congestion and pain Uses

  • 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

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 dosage

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 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

Inactive ingredients

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

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Tylenol® Sinus Congestion & Pain Daytime active ingredients

SEE NEW WARNINGS & DIRECTIONS

Cool Ice®

Instant Cooling Sensation

Pain & Sinus Congestion

Pain Reliever, Nasal Decongestant

Headache - Acetaminophen

Sinus Pressure / Nasal Congestion - Phenylephrine HCl

Actual Size

Non-Drowsy

DayTime

sinus congestion and pain
Pain & Sinus Congestion Carton Image 1 Pain & Sinus Congestion Carton Image 2

sinus congestion and pain

Acetaminophen, Phenylephrine HCl TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:41250-272
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
ACESULFAME POTASSIUM
carnauba wax
CROSPOVIDONE
cellulose, microcrystalline
POLYETHYLENE GLYCOLS
POLYVINYL ALCOHOL
povidone
STEARIC ACID
talc
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
GREEN 16 mm L272 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 12 in 1 BLISTER PACK
2 NDC:41250-272-62 2 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2007-01-17


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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