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

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Nighttime Cold Head Congestion

FRED'S, INC.

Freds 44-473C


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each caplet)

Acetaminophen 325 mg
Chlorpheniramine maelate 2 mg
Dextromethorphan HBr  10 mg
Phenylephrine HCl 5 mg 

Purpose

Pain reliever/fever reducer
Antihistamine
Cough suppressant
Nasal decongestant 

Nighttime Cold Head Congestion Uses

  • 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
  • temporarily reduces fever 

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

Sore throat warning: If sore throat is severe, presists for more than 2 days, is accompained 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, 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
  • 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 phlem (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
  • be careful when driving a motor vehicle or operating machinery
  • marked drowsiness may occur 

Stop use and ask a doctor if

  • nervousness, diziness, 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. 

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

Nighttime Cold Head Congestion Other information

  • store at controlled room temperature 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

Inactive ingredients

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

Questions or comments?

1-800-426-9391

Principal display panel

FRED'S®

Nighttime
Pseudoephedrine Free

Cold
Head Congestion

Headache/Sore Throat - Acetaminophen
Nasal Congestion - Phenylephrine HCl
Coughing - Dextromethorphan HBr
Runny Nose - Chlorpheniramine maleate

Pain Reliever,
Nasal Decongestant,
Cough Suppressant,
Antihistamine

24 Cool Caplets
with Cool Blast Flavor

Compare To:
The Active Ingredient in Tylenol® Cold Head Congestion Nighttime*

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

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® Cold Head Congestion Nighttime.
50844      REV0410D47308

Nighttime Cold Head Congestion
Fred's 44-473

Nighttime Cold Head Congestion

Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl CAPSULE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55315-473
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg
Chlorpheniramine Maleate CHLORPHENIRAMINE 2 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 10 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
FD&C BLUE NO. 1
cellulose, microcrystalline
talc
Sucralose
STARCH, CORN

Product Characteristics

Color Size Imprint Code Shape
BLUE 17 mm 44;473 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 24 in 1 BLISTER PACK
2 NDC:55315-473-08 1 in 1 CARTON

Marketing Information

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


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