Dover Coldonyl description, usages, side effects, indications, overdosage, supplying and lots more!

Dover Coldonyl

Unifirst First Aid Corporation

  • 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
Dover Coldonyl

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredients (in each tablet)

Acetaminophen 325 mg

Guaifenesin 100mg

Phenylephrine Hydrochloride 5mg

Purposes

Pain reliever/ fever reducer

Expectorant

Nasal decongestant

Uses

Temporarily relieves minor aches and pains associated with

  • headache
  • muscular aches
  • minor arthritis pain
  • common cold
  • toothache
  • menstrual cramps

Temporarily relieves nasal congestion due to

  • common cold
  • hay fever or other respiratory allergies

Temporarily

  • reduces fever
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • promotes nasal and/or sinus drainage; relieves sinus congestion and pressure

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 12 tablets 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.
  • for more than 10 days for pain unless directed by a doctor
  • for more than 3 days for fever unless directed by a doctor
  • with any other drug using the above active ingredients
  • 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.

Ask a doctor before use if you have

  • liver disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • heart disease
  • difficulty in urination due to enlargement of the prostate gland
  • a persistent chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema or where cough is accompanied by excessive phlegm (mucus)

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin

Stop use and ask a doctor if

  • cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
  • symptoms do not improve within 7 days or are accompanied by a fever
  • pain or fever persists or gets worse
  • redness or swelling is present
  • any new symptoms occur

Do not exceed recommended dosage. If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor.

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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • do not use more than directed

Adults and children (12 years and older): Take 2 tablets with water every 4 to 6 hours. Do not take more than 12 tablets in 24 hours.

Children under 12 years: Do not give to children under 12 years of age.

Other information

  • store at room temperature 59º-86ºF (15º-30ºC)
  • tamper evident sealed packets
  • do not use any opened or torn packets
  • avoid excessive heat and humidity

Inactive ingredients

FD&C red #40, maltodextrin, microcrystalline cellulose, povidone, sodium starch glycolate, starch, stearic acid

Questions or comments? 1-800-634-7680

106R Dover Coldonyl Label

Dover Coldonyl

Decongestant-Expectorant

Pain Reliever/Fever Reducer

Cold, Hay Fever & Sinus Relief

Without Danger of Drowsiness

See new warnings information

Acetaminophen 325 mg

Guaifenesin 100 mg

Phenylephrine HCl 5 mg

Dover Pharmaceutical

Products of the highest quality and effectiveness

Tamper Resistant

Sealed Packets

Unit Dose Packs

500 Tablets

(250 Packets of 2)

Dover Coldonyl

ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:47682-307
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg
Guaifenesin GUAIFENESIN 100 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
cellulose, microcrystalline
FD&C RED NO. 40
maltodextrin
povidone
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
STEARIC ACID

Product Characteristics

Color Size Imprint Code Shape
pink (pink) 12 mm FR;40 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:47682-307-99 2 in 1 PACKET
2 NDC:47682-307-13 250 in 1 BOX, UNIT-DOSE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2008-12-30


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