Delsym

Manufacturer: RB Health (US) LLC
Effective date: 2022-01-12
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-01 22:17:59

Label at a glance#

ProductDelsym Cough Plus Cold Day Time

Active ingredientacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride

Label structure10 sections

Indications and uses

temporarily relieves these common cold and flu symptoms: nasal congestion cough minor aches and pains sore throat headache temporarily reduces fever sinus congestion and pressure temporarily promotes nasal and/or sinus drainage helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Dosage and administration

do not take more than directed (see Overdose warning ) do not take more than 6 packets in any 24-hour period adults and children 12 years of age and older: 1 packet every 4 hours Dissolve contents of one packet into 8 oz of hot water and stir; sip while hot. Consume within 15 minutes. children under 12 years of age: do not use

Storage and handling

each packet contains: sodium 130 mg phenylketonurics: contains phenylalanine 41 mg per packet store between 20-25°C (68-77°F) protect from excessive heat and moisture

Contacts and useful links#

PhoneLabel contact1-888-963-3382

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

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

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these common cold and flu symptoms:

nasal congestion
cough
minor aches and pains
sore throat
headache
temporarily reduces fever
sinus congestion and pressure
temporarily promotes nasal and/or sinus drainage
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

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

more than 6 packets 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

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.
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
heart disease
diabetes
high blood pressure
thyroid disease
trouble urinating due to an enlarged prostate gland
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
cough that occurs with too much phlegm (mucus)
a sodium-restricted diet

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

OTC - WHEN USING SECTION

When using this product do not use more than directed

Stop use and ask a doctor if

OTC - STOP USE SECTION

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.

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.

Overdose warning

OVERDOSAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

do not take more than directed (see Overdose warning)
do not take more than 6 packets in any 24-hour period
adults and children 12 years of age and older: 1 packet every 4 hours
Dissolve contents of one packet into 8 oz of hot water and stir; sip while hot. Consume within 15 minutes.
children under 12 years of age: do not use

Other information

STORAGE AND HANDLING SECTION

each packet contains: sodium 130 mg
phenylketonurics: contains phenylalanine 41 mg per packet
store between 20-25°C (68-77°F)
protect from excessive heat and moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, aspartame, D&C Yellow #10, FD&C Red #40, flavors, saccharin sodium, sucrose, trisodium citrate dihydrate

Questions?

OTC - QUESTIONS SECTION

1-888-963-3382

You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 8 Packet Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 63824-112-08

NEW!

MAX Strength*

Delsym^®

COUGH +™ COLD

DAY TIME

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

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

HONEY LEMON
Flavored Mix

For Ages 12+

8 Packets

PRINCIPAL DISPLAY PANEL - 8 Packet Carton

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
acetaminophen	ACTIVE INGREDIENT	362O9ITL9D	1
dextromethorphan hydrobromide	ACTIVE INGREDIENT	9D2RTI9KYH	1
guaifenesin	ACTIVE INGREDIENT	495W7451VQ	1
phenylephrine hydrochloride	ACTIVE INGREDIENT	04JA59TNSJ	1
acetaminophen	ACTIVE MOIETY	362O9ITL9D	1
dextromethorphan	ACTIVE MOIETY	7355X3ROTS	1
guaifenesin	ACTIVE MOIETY	495W7451VQ	1
phenylephrine	ACTIVE MOIETY	1WS297W6MV	1
anhydrous citric acid	INACTIVE INGREDIENT	XF417D3PSL	1
aspartame	INACTIVE INGREDIENT	Z0H242BBR1	1
D&C Yellow No. 10	INACTIVE INGREDIENT	35SW5USQ3G	1
FD&C Red No. 40	INACTIVE INGREDIENT	WZB9127XOA	1
saccharin sodium	INACTIVE INGREDIENT	SB8ZUX40TY	1
sucrose	INACTIVE INGREDIENT	C151H8M554	1
trisodium citrate dihydrate	INACTIVE INGREDIENT	B22547B95K	1

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

Delsym Cough Plus Cold Day Time
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
acetaminophen
dextromethorphan hydrobromide
dextromethorphan
guaifenesin
phenylephrine hydrochloride
phenylephrine
anhydrous citric acid
aspartame
D&C Yellow No. 10
FD&C Red No. 40
saccharin sodium
sucrose
trisodium citrate dihydrate

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63824-112	63824-112-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
acetaminophen	362O9ITL9D	ACTIB
dextromethorphan hydrobromide	9D2RTI9KYH	ACTIB
guaifenesin	495W7451VQ	ACTIB
phenylephrine hydrochloride	04JA59TNSJ	ACTIB
anhydrous citric acid	XF417D3PSL	IACT
aspartame	Z0H242BBR1	IACT
D&C Yellow No. 10	35SW5USQ3G	IACT
FD&C Red No. 40	WZB9127XOA	IACT
saccharin sodium	SB8ZUX40TY	IACT
sucrose	C151H8M554	IACT
trisodium citrate dihydrate	B22547B95K	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 268 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION / RECTAL		904 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		414 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
FD&C Red No. 40	FD&C RED NO. 40	WZB9127XOA	TABLET / ORAL		7 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET / ORAL		197 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
aspartame	ASPARTAME	Z0H242BBR1	TABLET, FILM COATED / ORAL		20 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
D&C Yellow No. 10	D&C YELLOW NO. 10	35SW5USQ3G	CONCENTRATE / ORAL	0.03 mg/1ml		Exact identifier — unii candidate 31 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	GRANULE, FOR SOLUTION / ORAL		42596 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / ORAL		665 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION, SOLUTION / INTRAMUSCULAR		25 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	POWDER, FOR SOLUTION / ORAL		38666 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
D&C Yellow No. 10	D&C YELLOW NO. 10	35SW5USQ3G	SOLUTION / RECTAL	NA		Exact identifier — unii candidate 31 equally ranked IID candidates
D&C Yellow No. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET, DELAYED RELEASE / ORAL	1.9 mg		Exact identifier — unii candidate 31 equally ranked IID candidates
aspartame	ASPARTAME	Z0H242BBR1	LOZENGE / ORAL		136 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
trisodium citrate dihydrate	TRISODIUM CITRATE DIHYDRATE	B22547B95K	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		800 mg	Exact identifier — unii candidate 47 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	LIQUID / ORAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
trisodium citrate dihydrate	TRISODIUM CITRATE DIHYDRATE	B22547B95K	INJECTION, SOLUTION / INTRA-ARTICULAR		25 mg	Exact identifier — unii candidate 47 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION, SOLUTION / INTRAVENOUS		772 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		18790 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SOLUTION / TOPICAL	4.35 %w/v		Exact identifier — unii candidate 61 equally ranked IID candidates
trisodium citrate dihydrate	TRISODIUM CITRATE DIHYDRATE	B22547B95K	TABLET, EXTENDED RELEASE / ORAL		300 mg	Exact identifier — unii candidate 47 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, FOR SUSPENSION / ORAL		6 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION / INTRACARDIAC		25 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	POWDER / ORAL		27768 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION / PERINEURAL	0.02 %w/v		Exact identifier — unii candidate 61 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, CHEWABLE / ORAL		4 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
trisodium citrate dihydrate	TRISODIUM CITRATE DIHYDRATE	B22547B95K	SHAMPOO / TOPICAL		186 mg	Exact identifier — unii candidate 47 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	INJECTION / INTRAVENOUS		1950 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	INJECTABLE, LIPOSOMAL / INTRAVENOUS		7560 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SOLUTION / ORAL		3900 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
FD&C Red No. 40	FD&C RED NO. 40	WZB9127XOA	TABLET / BUCCAL	0.01 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / BUCCAL	0.4 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
trisodium citrate dihydrate	TRISODIUM CITRATE DIHYDRATE	B22547B95K	SOLUTION / INTRAMUSCULAR	0.03 %w/v		Exact identifier — unii candidate 47 equally ranked IID candidates
D&C Yellow No. 10	D&C YELLOW NO. 10	35SW5USQ3G	GEL / TOPICAL	NA		Exact identifier — unii candidate 31 equally ranked IID candidates
trisodium citrate dihydrate	TRISODIUM CITRATE DIHYDRATE	B22547B95K	SUSPENSION/ DROPS / OPHTHALMIC		7 mg	Exact identifier — unii candidate 47 equally ranked IID candidates
FD&C Red No. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, FILM COATED / ORAL	2.5 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
trisodium citrate dihydrate	TRISODIUM CITRATE DIHYDRATE	B22547B95K	SPRAY / NASAL		9 mg	Exact identifier — unii candidate 47 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	900 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	SUSPENSION / ORAL	5000 mg/5ml		Exact identifier — unii candidate 34 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SPRAY / NASAL		5 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
D&C Yellow No. 10	D&C YELLOW NO. 10	35SW5USQ3G	SYRUP / ORAL		4 mg	Exact identifier — unii candidate 31 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION, SOLUTION / SUBCUTANEOUS		25 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
aspartame	ASPARTAME	Z0H242BBR1	POWDER / ORAL		63 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / ORAL		43 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
FD&C Red No. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, COATED / ORAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
trisodium citrate dihydrate	TRISODIUM CITRATE DIHYDRATE	B22547B95K	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUS	0.03 mg		Exact identifier — unii candidate 47 equally ranked IID candidates
FD&C Red No. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, LIQUID FILLED / ORAL		1 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C Red No. 40	FD&C RED NO. 40	WZB9127XOA	SUSPENSION / ORAL	100 mg/5ml		Exact identifier — unii candidate 28 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	GRANULE, FOR SOLUTION / ORAL	5.5 mg/120ml		Exact identifier — unii candidate 34 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	INJECTION / INTRAVENOUS		22 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, FILM COATED / ORAL	2 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	PASTE, DENTIFRICE / DENTAL	0.2 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
trisodium citrate dihydrate	TRISODIUM CITRATE DIHYDRATE	B22547B95K	INJECTION, SOLUTION, CONCENTRATE / IRRIGATION		22 mg	Exact identifier — unii candidate 47 equally ranked IID candidates
D&C Yellow No. 10	D&C YELLOW NO. 10	35SW5USQ3G	SOAP / TOPICAL	1.4 %w/w		Exact identifier — unii candidate 31 equally ranked IID candidates
trisodium citrate dihydrate	TRISODIUM CITRATE DIHYDRATE	B22547B95K	INJECTION, SUSPENSION / INTRAVITREAL	0.17 %w/v		Exact identifier — unii candidate 47 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS	9.4 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
trisodium citrate dihydrate	TRISODIUM CITRATE DIHYDRATE	B22547B95K	GEL / TOPICAL	0.18 %w/w		Exact identifier — unii candidate 47 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION / RESPIRATORY (INHALATION)		1 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
aspartame	ASPARTAME	Z0H242BBR1	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		78 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION/ DROPS / ORAL		15 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	PASTE / ORAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
082c1e69-08fb-99c5-e063-6394a90ad658			ce07952b-4a0f-4d72-b7f9-c032f89ec1f5	2023-10-20	Warnings	Exact identifier spl set id: ce07952b-4a0f-4d72-b7f9-c032f89ec1f5

Reported adverse events (FAERS/openFDA)#

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