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

Delsym Night Time Cough and Cold

Reckitt Benckiser, Inc.

  • 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 NIGHT TIME COUGH & COLD

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active ingredients (in each 15 mL) Purpose
Acetaminophen 500 mg Pain reliever/Fever reducer
Dextromethorphan HBr 15 mg Cough suppressant
Doxylamine Succinate 6.25 mg Antihistamine

Uses

temporarily relieves these common cold and flu symptoms:

  • cough due to minor throat and bronchial irritation
  • runny nose and sneezing
  • minor aches and pains
  • sore throat
  • headache
  • fever
  • the impulse to cough to help you get to sleep

Warnings

Liver warning

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

  • more than 4 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing 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.
  • 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
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • persistent or chronic cough such as occurs with smoking, asthma or emphysema
  • cough that occurs with too much phlegm (mucus)
  • a sodium restricted diet

Ask a doctor or pharmacist before use if

  • you are taking the blood thinning drug warfarin.
  • you are taking sedatives or tranquilizers.

When using this product

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

Stop use and ask a doctor if

  • pain 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 persistent headache. 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 4 doses in any 24-hour period
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
  • mL = milliliter
  • Adults and Children 12 years and older: 30 mL in dosing cup provided every 6 hours.
  • Children under 12 years of age: Do not use.

Other information

  • each 15 mL contains: sodium 23 mg
  • tamper evident: do not use if seal under bottle cap printed "SEALED for YOUR PROTECTION" is torn or missing
  • dosing cup provided
  • store between 15-30°C (59-86°F)
  • Keep carton for full directions for use

Inactive ingredients

anhydrous citric acid, anhydrous trisodium citrate, FD&C Blue #1, FD&C Red #40, flavors, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sugar

Questions?

1-888-963-3382.

You may also report side effects to this phone number.

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

PRINCIPAL DISPLAY PANEL - 120 mL Carton

SEE NEW WARNINGS
& INGREDIENTS

Delsym ®

NIGHT
TIME

COUGH & COLD

Acetaminophen
(Pain Reliever / Fever Reducer)

Dextromethorphan HBr (Cough Suppressant)
Doxylamine succinate (Antihistamine)

  • Cough
  • Runny Nose & Sneezing
  • Sore Throat
  • Body Aches

Liquid
120 mL (4 fl oz)
for Ages 12+

PRINCIPAL DISPLAY PANEL - 120 mL Carton

Delsym Night Time Cough and Cold

Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine Succinate SOLUTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63824-182
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 500 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 15 mg
DOXYLAMINE SUCCINATE DOXYLAMINE 6.25 mg

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS CITRIC ACID
ANHYDROUS TRISODIUM CITRATE
FD&C BLUE NO. 1
FD&C RED NO. 40
GLYCERIN
polyethylene glycol
propylene glycol
water
saccharin sodium
SODIUM BENZOATE
SUCROSE

Product Characteristics

Color
RED

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 120 in 1 BOTTLE
2 NDC:63824-182-64 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2010-04-06


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Be sure to consult your doctor before taking any medication!
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