Delsym Cough Plus Chest Congestion DM and Delsym Cough Plus Cold Night Time

Manufacturer
RB Health (US) LLC
Effective date
2022-06-22
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:58:27

Label at a glance#

ProductDelsym Cough Plus Chest Congestion DM and Delsym Cough Plus Cold Night Time
Active ingredientDextromethorphan Hydrobromide, Guaifenesin, Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride
Label structure12 sections

Indications and uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough temporarily relieves these common cold and flu symptoms: cough nasal congestion minor aches and pai...

Dosage and administration

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 do not use dosing cup with other products dose as follows or as directed by a doctor adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours children under 12 years of age: do not use

Storage and handling

each 20 mL contains: sodium 13 mg store between 20-25°C (68-77°F) do not refrigerate

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each 20 mL) Delsym Cough+ Chest Congestion DMPurposes
Dextromethorphan HBr 20 mgCough suppressant
Guaifenesin 400 mgExpectorant

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each 20 mL) Delsym Cough+ Cold Night TimePurposes
Acetaminophen 650 mgPain reliever/fever reducer
Diphenhydramine HCl 25 mgAntihistamine/cough suppressant
Phenylephrine HCl 10 mgNasal decongestant

Uses

INDICATIONS & USAGE SECTION

Delsym Cough+ Chest Congestion DM

SPL UNCLASSIFIED SECTION

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • temporarily relieves:
    • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    • the intensity of coughing
    • the impulse to cough

Delsym Cough+ Cold Night Time

SPL UNCLASSIFIED SECTION

  • 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 you get to sleep

Warnings

WARNINGS SECTION

Liver warning (Night Time only)

SPL UNCLASSIFIED SECTION

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 containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product

Allergy alert (Night Time only)

SPL UNCLASSIFIED SECTION

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 (Night Time only)

SPL UNCLASSIFIED SECTION

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

OTC - DO NOT USE SECTION

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. (Night Time only)
  • with any other product 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

OTC - ASK DOCTOR SECTION

  • liver disease (Night Time only)
  • heart disease (Night Time only)
  • high blood pressure (Night Time only)
  • glaucoma (Night Time only)
  • thyroid disease (Night Time only)
  • diabetes (Night Time only)
  • trouble urinating due to an enlarged prostate gland (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

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking the blood thinning drug warfarin (Night Time only)
  • taking sedatives or tranquilizers (Night Time only)

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • nervousness, dizziness, or sleeplessness occur (Night Time only)
  • pain, nasal congestion, or cough gets worse or lasts more than 7 days (Night Time only)
  • fever gets worse or lasts more than 3 days (Night Time only)
  • redness or swelling is present (Night Time only)
  • new symptoms occur (Night Time only)
  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Overdose warning (Night Time only)

SPL UNCLASSIFIED SECTION

Taking more than the recommended dose (overdose) may cause liver damage. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
  • adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours
  • children under 12 years of age: do not use

Other information

STORAGE AND HANDLING SECTION

  • each 20 mL contains: sodium 13 mg
  • store between 20-25°C (68-77°F)
  • do not refrigerate

Inactive ingredients (Delsym Cough+ Chest Congestion DM)

INACTIVE INGREDIENT SECTION

anhydrous citric acid, edetate disodium, FD&C red no. 40, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate1, xanthan gum

1 may contain this ingredient

Inactive ingredients (Delsym Cough+ Cold Night Time)

INACTIVE INGREDIENT SECTION

anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate1, xanthan gum

Questions?

OTC - QUESTIONS SECTION

1-866-682-4639

SPL UNCLASSIFIED SECTION

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

Made in England

PRINCIPAL DISPLAY PANEL - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DAY
NIGHT

NDC 63824-220-22

COMBO
PACK

Delsym®

COUGH+®
CHEST
CONGESTION

DM
Dextromethorphan HBr (Cough Suppressant)
Guaifenesin (Expectorant)

  • Cough
  • Chest Congestion
  • Thins & Loosens Mucus

Cherry
Flavored Liquid

COUGH+®COLD

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

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

Mixed Berry
Flavored Liquid

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

PRINCIPAL DISPLAY PANEL - Kit Carton
PRINCIPAL DISPLAY PANEL - Kit Carton

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63824-220-22ML - Milliliter63824-2206c979edd-d247-4cbb-a15e-7a58ae5601cd12019-08-06
63824-213-66ML - Milliliter63824-213447d0a46-bb82-40da-8d50-611a7917b14012013-12-02
63824-211-66ML - Milliliter63824-211b8406c8c-6da9-44bc-95a4-14b0c8d682f212013-12-02

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63824-22063824-220-22
63824-21363824-213-66
63824-21163824-211-66

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Delsym Cough Plus Chest Congestion DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINReckitt Benckiser LLC8252cdec-b668-4450-b045-e093479ab5422026-05-27WarningsExact identifier
ndc (package): 63824-213-66
ndc (product): 63824-213
ndc11 (package): 63824021366
00dd71d1-ec2f-f8aa-e063-6294a90ae430211b5ef8-0de8-441b-b1de-eba943d7c8b12023-07-19WarningsExact identifier
spl set id: 211b5ef8-0de8-441b-b1de-eba943d7c8b1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.