Sinus Congestion and Pain Severe description, usages, side effects, indications, overdosage, supplying and lots more!

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Sinus Congestion and Pain Severe

ARMY AND AIR FORCE EXCHANGE SERVICE

Exchange Select 44-527C


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Acetaminophen 325 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever
Expectorant
Nasal decongestant

Sinus Congestion and Pain Severe Uses

  • for the temporary relief of:
    • headache
    • sinus congestion and pressure
    • nasal congestion
    • minor aches and pain
  • helps loosen phlegm (mucus) and thin bronchial secretons to make coughs more productive
  • temporarily relieves nasal congestion due to the common cold and hay fever and other upper respiratory allergies

Warnings

 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
  • diabetes
  • heart disease
  • high blood pressure
  • thyroid disease
  • trouble urinating due to an englarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you have

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, nasal congestion, or cough gets worse or lasts more than 7 days
  • fever gets worse of lasts more than 3 days
  • redness or swelling is present
  • cough comes back or occurs with rash or headache that lasts
  • 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: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs of symptoms.

Directions

  • do not take more than directed
    (see overdose 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 12 caplets in 24 hours
  • children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Sinus Congestion and Pain Severe Other information

  • store at 25ºC (77ºF); excursion permitted between 15º - 30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

Inactive ingredients

corn starch, crospovidone, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, silicone dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Principal Display Panel

Pseudoephedrine Free

Compare To The Active Ingredient of Tylenol® Sinus Congestion & Pain Severe Daytime*

exchange
select™

SINUS
CONGESTION & PAIN
SEVERE
Pain Releiver, Nasal Decongestant, Expectorant

DAYTIME Non-Drowsy
CONTAINS 3 MEDICINES

Headache - Acetaminophen
Sinus Pressure/Nasal Congestion - Phenylephrine HCl
Chest Congestion - Guaifenesin

24 COOL CAPLETS with Cool Blast Flavor

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® Sinus Congestion & Pain Severe Daytime Caplets.
50844        REV0512A52708

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

Sinus Congestion and Pain Severe
Exchange Select 44-527C

Sinus Congestion and Pain Severe

Aceetaminophen, Guaifenesin and Phenylephrine HCl TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55301-527
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg
Guaifenesin GUAIFENESIN 200 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
CROSPOVIDONE
MAGNESIUM STEARATE
maltodextrin
cellulose, microcrystalline
POLYETHYLENE GLYCOLS
POLYVINYL ALCOHOL
POVIDONES
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Sucralose
talc
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
WHITE 19 mm 44;527 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 24 in 1 BLISTER PACK
2 NDC:55301-527-08 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2005-08-06


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