Delsym Cough Plus Cold Day Time and Delsym Cough Plus Cold Night Time description, usages, side effects, indications, overdosage, supplying and lots more!

Delsym Cough Plus Cold Day Time and Delsym Cough Plus Cold Night Time

Reckitt Benckiser 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
Delsym Cough Plus™ Cold Day Time and Delsym Cough Plus™ Cold Night Time

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active ingredients (in each 20 mL)
Delsym Cough+ Cold Day Time
Purposes
Acetaminophen 650 mg Pain reliever/fever reducer
Dextromethorphan HBr 20 mg Cough suppressant
Guaifenesin 400 mg Expectorant
Phenylephrine HCl 10 mg Nasal decongestant

Active ingredient

Purpose

Active ingredients (in each 20 mL)
Delsym Cough+ Cold Night Time
Purposes
Acetaminophen 650 mg Pain reliever/fever reducer
Diphenhydramine HCl 25 mg Antihistamine/ cough suppressant
Phenylephrine HCl 10 mg Nasal decongestant

Uses

  • temporarily relieves these common cold and flu symptoms:
    • nasal congestion
    • cough
    • minor aches and pains
    • headache
    • sore throat
    • runny nose and sneezing (Night Time only)
  • controls cough to help you get to sleep
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (Day Time only)
  • temporarily reduces fever

Warnings

Liver warning

This product contains acetaminophen.

Severe liver damage may occur if you take:

  • more than 6 doses in 24 hours, which is the maximum daily amount
  • with other drugs that contain acetaminophen
  • 3 or more alcoholic drinks daily 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.
  • with any other drug containing diphenhydramine, even one used on the skin (Night Time only)
  • 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
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • glaucoma (Night Time only)
  • a breathing problem such as emphysema or chronic bronchitis (Night Time only)
  • 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
  • taking sedatives or tranquilizers (Night Time only)

When using this product

  • do not use more than directed
  • excitability may occur, especially in children (Night Time only)
  • marked drowsiness may occur (Night Time only)
  • alcohol, sedatives, and tranquilizers may increase drowsiness (Night Time only)
  • avoid alcoholic drinks (Night Time only)
  • be careful when driving a motor vehicle or operating machinery (Night Time only)

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 fever, 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)
  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided with product
  • dose as follows or as directed by a doctor
  • mL = milliliter
  • adults and children 12 years and older: 20 mL in dosing cup provided every 4 hours
  • children under 12 years of age: do not use

Other information

  • each 20 mL contains: sodium 12 mg
  • do not refrigerate
  • store between 20-25°C (68-77°F)
  • dosing cup provided

Inactive ingredients (Delsym Cough+ Cold Day Time)

anhydrous citric acid, edetate disodium, FD&C Blue #1, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydratemay contain this ingredient, xanthan gum

Inactive ingredients (Delsym Cough+ Cold Night Time)

anhydrous citric acid, edetate disodium, FD&C Blue #1, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydratemay contain this ingredient, xanthan gum

Questions?

1-888-963-3382

Dist. by: Reckitt Benckiser
Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - Kit Carton

NDC 63824-217-22

COMBO
PACK

Delsym ®

COUGH+™COLD

DAY TIME

Acetaminophen (Pain Reliever/Fever Reducer)
Dextromethorphan HBr (Cough Suppressant)
Guaifenesin (Expectorant)
Phenylephrine HCl (Nasal Decongestant)

✓ Cough ✓ Sore Throat ✓ Headache
✓ Nasal & Chest Congestion ✓ Fever

NIGHT TIME

Acetaminophen (Pain Reliever/Fever Reducer)
Diphenhydramine HCl (Antihistamine/Cough Suppressant)
Phenylephrine HCl (Nasal Decongestant)

✓ Cough ✓ Sore Throat ✓ Fever
✓ Nasal Congestion ✓ Body Aches

TWO – 6 fl oz (180 mL) bottles
TOTAL – 12 fl oz (360 mL)

For Ages 12+

Mixed Berry
Flavored Liquid

PRINCIPAL DISPLAY PANEL - Kit Carton

Delsym Cough Plus Cold Day Time and Delsym Cough Plus Cold Night Time

Acetaminophen, Dextromethorphan Hydrobromide, Diphenhydramine Hydrochloride, Guaifenesin, and Phenylephrine Hydrochloride KIT

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63824-217
Route of Administration DEA Schedule

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:63824-217-22 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2014-04-01


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