Severe Cold and Congestion Maximum Strength description, usages, side effects, indications, overdosage, supplying and lots more!

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Severe Cold and Congestion Maximum Strength

WOONSOCKET PRESCRIPTION CENTER,INCORPORATED

CVS 44-617


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each caplet)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/Fever reducer
Cough suppressant
Expectorant
Nasal Decongestant 

Severe Cold and Congestion Maximum Strength Uses

  • temporarily relieves these common cold and flu symptoms:
    • nasal congestion
    • cough
    • headache
    • minor aches and pains
  • temporarily reduces fever
  • temporarily promotes nasal and/or sinus drainage
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

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 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 don't 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 enlarged 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 are

taking the blood thinning drug warfarin.

When using this product

do not exceed the recommended dosage. 

Stop use and ask a doctor if

  • new symptoms occur
  • pain, nasal congestion, or cough gets worse or lasts more than 7 days
  • redness or swelling is present
  • nervousness, dizziness, or sleeplessness occur
  • cough comes back or occurs with rash or headache that lasts
  • fever gets worse or lasts more than 3 days

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 overodse, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 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 overdose warning)
  • do not take more than 12 caplets in any 24-hour period
  • adults and children 12 years and older: take 2 caplets every 4 hours
  • children under 12 years of age: do not use

Severe Cold and Congestion Maximum Strength Other information

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • use by expiration date on package

Inactive ingredients

corn starch, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, mangesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, talc, titanium dioxide 

Questions or comments?

1-800-426-9391

Principal display panel

CVS
pharmacy™

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

MULTI-SYMPTOM

Compare to the active ingredients in Maximum Strength Mucinex® FAST-MAX™ Severe Congestion & Cold*

NEW!

SEVERE
CONGESTION
& COLD
MAXIMUM STRENGTH

Relieves Pain & Reduces Fever - Acetaminophen
Soothes Cough - Dextromethorphan HBr
Thins & Loosens Mucus - Guaifenesin
Relieves Sinus Pressure & Nasal Congestion - Phenylephrine HCl

PAIN RELIEVER/FEVER REDUCER, NASAL DECONGESTANT, EXPECTORANT, COUGH SUPPRESSANT

30 Caplets

For Ages 12+

*This product is not manufactured or distributed by Reckitt Benckiser LLC, owner of the registered trademark Maximum Strength Mucinex® FAST-MAX™ Severe Congestion & Cold.
50844    REV0313A61701

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
(c) 2013 CVS/pharmacy
www.cvs.com    1-800-shop-CVS    V-19849

Severe Cold and Congestion Maximum Strength

CVS 44-617 [Front] CVS 44-617 [Back]

Severe Cold and Congestion Maximum Strength

Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:59779-761
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 10 mg
Guaifenesin GUAIFENESIN 200 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
STARCH, CORN
CROSPOVIDONE
FD&C RED NO. 40
FD&C YELLOW NO. 6
MAGNESIUM STEARATE
maltodextrin
titanium dioxide
talc
POLYVINYL ALCOHOL
POVIDONES
STEARIC ACID

Product Characteristics

Color Size Imprint Code Shape
RED 19 mm 44;617 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 10 in 1 BLISTER PACK
2 10 in 1 BLISTER PACK
3 NDC:59779-761-09 2 in 1 PACKAGE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2013-04-07


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Be sure to consult your doctor before taking any medication!
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