dg health cold head congestion severe description, usages, side effects, indications, overdosage, supplying and lots more!

dg health cold head congestion severe

Dolgencorp, LLC

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Dolgencorp, LLC Cold Head Congestion Drug Facts

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

Uses

  • •for the temporary relief of the following cold/flu symptoms:
  • •minor aches and pains
  • •headache
  • •sore throat
  • •nasal congestion
  • •cough
  • •impulse to cough
  • •helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • •temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) 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 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.
  • •if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

  • •liver disease
  • •heart disease
  • •high blood pressure
  • •thyroid disease
  • •diabetes
  • •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 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 or lasts more than 3 days
  • •redness or swelling is present
  • •new symptoms occur
  • •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.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) 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 Liver warning)
take 2 caplets every 4 hours
  • swallow whole – do not crush, chew or dissolve
  • do not take more than 10 caplets in 24 hours

    adults and children 12 years and over

    children under 12 years

    ask a doctor

    Other information

    • •each caplet contains: sodium 3 mg

    Inactive ingredients

    acesulfame potassium, carnauba wax, croscarmellose sodium, crospovidone, D&C yellow #10 aluminum lake, flavor, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide

    Questions?

    1-888-309-9030

    Principal Display Panel

    Compare to active ingredients of Tylenol® Cold Head Congestion Severe

    Day Time

    Cold Head Congestion

    Severe

    Pain Reliever/Fever Reducer - Acetaminophen

    Nasal Decongestant - Phenylephrine HCl

    Cough Suppressant - Dextromethorphan HBr

    Expectorant - Guaifenesin

    SEE NEW WARNINGS AND DIRECTIONS

    INSTANT COOLING SENSATION

    Cool Ice®

    dg health cold head congestion severe

    Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, COATED

    Product Information

    Product Type Human otc drug label Item Code (Source) NDC:55910-234
    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
    ACESULFAME POTASSIUM
    carnauba wax
    CROSCARMELLOSE SODIUM
    CROSPOVIDONE
    maltodextrin
    cellulose, microcrystalline
    POLYETHYLENE GLYCOLS
    POLYVINYL ALCOHOL
    POVIDONES
    SILICON DIOXIDE
    STEARIC ACID
    talc
    titanium dioxide

    Product Characteristics

    Color Size Imprint Code Shape
    YELLOW 20 mm L234 OVAL

    Packaging

    # Item Code Package Description Marketing Start Date Marketing End Date
    1 12 in 1 BLISTER PACK
    2 NDC:55910-234-62 2 in 1 CARTON

    Marketing Information

    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    part part341 2010-02-26


    PLEASE, BE CAREFUL!
    Be sure to consult your doctor before taking any medication!
    Copyright © 2014. drugs-library.com. All rights reserved. Information on drugs-library.com is provided for educational purposes only and is not to be used for medical advice, diagnosis or treatment.
    Support info@drugs-library.com.