Multi-Symptom Cold Flu and Sore Throat description, usages, side effects, indications, overdosage, supplying and lots more!

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Multi-Symptom Cold Flu and Sore Throat

Wal-Mart Stores Inc

Equate 44-616


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

Multi-Symptom Cold Flu and Sore Throat Uses

  • temporarily relieves these common cold and flu symptoms:
    • nasal congestion
    • sore throat
    • headache
    • minor aches and pains
    • cough
  • temporarily reduces fever
  • 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
  • 3 or more alcoholic drinks every day while using this product
  • with other drugs containing acetaminophen

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly..

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 using 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 exeed 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 overdose, 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

Multi-Symptom Cold Flu and Sore Throat 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 blue #1 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions

1-877-287-1915

Principal display panel

equate®

NDC 49035-616-01

Compare to Mucinex® Maximum Strength FAST-MAX™ Cold, Flu & Sore Throat Active Ingredients*

Maximum Strength
Multi-Symptom
Cold, Flu &
Sore Throat
Acetaminophen
325 mg /
Pain Reliever/Fever Reducer
Dextromethorphan HBr 10 mg /
Cough Suppressant
Guaifenesin 200 mg / Expectorant
Phenylephrine HCl 5 mg / Nasal Decongestant

• Relieves Headahce, Fever & Sore Throat
• Controls Cough
• Thins & Loosens Mucus
• Relieves Nasal & Chest Congestion

30
CAPLETS

Satisfaction guaranteed - for questions or comments please call 1-888-287-1915.

Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716
(c) Wal-Mart Stores, Inc.
*This product is not manufactured or distributed by Reckitt Benckiser LLC, owner of the registered trademark Maximum Strength Mucinex® FAST-MAX™ Cold, Flu & Sore Throat.
50844    ORG011361601

KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

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

Multi-Symptom Cold Flu and Sore Throat
CVS 44-616 [front] CVS 44-616 [back]

Multi-Symptom Cold Flu and Sore Throat

Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:49035-616
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 BLUE NO. 1
MAGNESIUM STEARATE
maltodextrin
POLYVINYL ALCOHOL
POVIDONES
STEARIC ACID
talc
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
BLUE 19 mm 44;616 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 10 in 1 BLISTER PACK
2 NDC:49035-616-01 3 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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