Head Congestion Daytime and Nighttime Cold description, usages, side effects, indications, overdosage, supplying and lots more!

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Head Congestion Daytime and Nighttime Cold

SUPERVALU INC.

Equaline 44-470C473


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine 5 mg

Pain reliever
Cough suppressant
Nasal decongestant 

Head Congestion Daytime and Nighttime Cold Uses

  • temporarily relieves these common cold symptoms:
    • minor aches and pains
    • headache
    • nasal congestion
    • cough
    • sore throat
    • sinus congestion and pressure
  • helps clear nasal passages 

Warnings

Liver warning: This product contains acetaminophen.  The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophnen) 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

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 taking a monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkison'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
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, 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 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
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • cough comes back or occurs with rash or headache that lasts. 

 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 or symptoms. 

  • do not use 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: ask a doctor
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number 

corn starch, croscarmellose sodium, crospovidone, flavor, magnesium stearate, microcrystalline cellulose, polytheylene glycol, polyvinyl alcohol, povidone, silica gel, stearic acid, sucralose, talc, titanium dioxide 

Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg
Dextromethorphan HBr 10 mg
Phenylephrine 5 mg

Pain reliever
Antihistamine
Cough suppressant
Nasal decongestant

  • temporarily relieves these common cold/flu symptoms:
    • minor aches and pains
    • headache
    • nasal congestion
    • cough
    • sore throat
    • sinus congestion and pressure
    • sneezing and runny nose
  • helps clear nasal passages
  • relieves cough to help you sleep

Warnings

Liver warning: This product contains acetaminophen.  The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophnen) 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

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 taking a monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkison"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
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • persistent or chronic cough such as occurs with smoking, asthma, 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 
  • taking sedatives or tranquilizers 

When using this product

  • do not exceed recommended dosage
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • be careful when driving a motor vehicle or operating machinery 

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
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • cough comes back or occurs with rash or headache that lasts. 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 or symptoms.

  • do not use 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
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

corn starch, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyetheylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide 

1-888-287-1915

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equaline®

compare to Tylenol® Cold Head Congestion Day and Night Caplets active ingredients**

NDC 41163-529-08

head congestion
daytime & nighttime cold
daytime formula
non-drowsy
contains 3 medicines:
headache/sore throat > acetaminophen
coughing > dextromethorphan HBr
nasal congestion > phenylephrine HCl

nighttime formula
contains 4 medicines:
headache/sore throat > acetaminophen
runny nose > chlorpheniramine maleate
coughing > detromethorphan HBr
nasal congestion > phenylephrine HCl
*antihistamine in nighttime only

pain reliever, nasal decongestant, cough suppressant, *antihistamine

24 cool caplets with cool blast flavor
12 daytime & 12 nighttime  

pseudoephedrine free

DOES NOT CONTAIN GLUTEN
**This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of registered trademark Tylenol® Cold Head Congestion Daytime & Nighttime.    50844    REV0113.470/473B08

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

Head Congestion Daytime and Nighttime Cold
Equaline 44-470C473

Head Congestion Daytime and Nighttime Cold

Acetaminophen, Chlorpehniramine HCl, Dextromethorphan HBr, Phenylephrine HCl KIT

Product Information

Product Type Human otc drug label Item Code (Source) NDC:41163-529
Route of Administration DEA Schedule

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:41163-529-08 1 in 1 PACKAGE, COMBINATION

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2005-07-21


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