Delsym 30 mg/5mL

Dextromethorphan · SUSPENSION, EXTENDED RELEASE · Reckitt Benckiser LLC

1 Recall on Record

Plain English

Delsym is a suspension, extended release containing dextromethorphan at 30 mg/5mL, taken oral. Manufactured by Reckitt Benckiser LLC.

Key Facts

Brand Name: Delsym
Generic Name: Dextromethorphan
NDC Code (Product): 63824-171
Manufacturer: Reckitt Benckiser LLC
Strength: 30 mg/5mL
Dosage Form: SUSPENSION, EXTENDED RELEASE
Route: ORAL
Marketing Status
Application #: NDA018658
Drug Class: Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]; Sigma-1 Agonist [EPC]
Marketing Start: 05/04/2010

Recall History

1 Recall on Record

Class II06/23/2022

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective1,625 reports

drug abuse987 reports

toxicity to various agents920 reports

overdose689 reports

dizziness588 reports

diarrhoea565 reports

completed suicide530 reports

accidental overdose448 reports

death428 reports

nausea418 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves these common cold and flu symptoms: cough nasal congestion minor aches and pains sore throat headache runny nose sneezing temporarily reduces fever controls cough to help your child get to sleep

Dosage & Administration

Directions this product does not contain directions or complete warnings for adult use do not give more than directed (see Overdose warning ) measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor children 6 to under 12 years of age: 10 mL in dosing cup provided every 4 hours while symptoms last; do not give more than 5 doses in any 24-hour period children under 6 years of age: do not use

Warnings

Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if your child takes: more than 5 doses in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen Allergy alert Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning I f 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. to make a child sleepy with any other product containing diphenhydramine, even one used on the skin in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. Ask…

Frequently Asked Questions

What is Delsym used for?

Delsym contains Dextromethorphan. It is a suspension, extended release taken oral. Consult your doctor for specific uses.

Is Delsym a controlled substance?

Delsym is not classified as a controlled substance by the DEA.

What is the generic name for Delsym?

The generic name for Delsym is Dextromethorphan. There are 12 other brand versions of Dextromethorphan.

What is the NDC code for Delsym 30 mg/5mL?

The NDC (National Drug Code) for Delsym 30 mg/5mL is 63824-171, listed by Reckitt Benckiser LLC.

Product NDC

63824-171

Package NDC

63824-171-22

Other Dextromethorphan Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)