Indications and uses
temporarily relieves these common cold and flu symptoms: cough minor aches and pains headache sore throat nasal congestion runny nose sneezing temporarily reduces fever controls cough to help you get to sleep
Delsym
- Manufacturer
- RB Health (US) LLC
- Effective date
- 2022-01-11
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:18:12
Label at a glance#
ProductDelsym Cough Plus Cold Night Time
Active ingredientAcetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride
Label structure10 sections
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)
Contacts and useful links#
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 |
| Diphenhydramine HCl 25 mg | Antihistamine/cough suppressant |
| Phenylephrine HCl 10 mg | Nasal decongestant |
Uses
- temporarily relieves these common cold and flu symptoms:
- cough
- minor aches and pains
- headache
- sore throat
- nasal congestion
- runny nose
- sneezing
- temporarily reduces fever
- controls cough to help you get to sleep
Warnings
Liver warning
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
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
- 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
- diabetes
- high blood pressure
- thyroid disease
- trouble urinating due to an enlarged prostate gland
- glaucoma
- breathing problems such as emphysema or chronic bronchitis
- 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
Ask a doctor or pharmacist before use if
- you are taking the blood thinning drug warfarin
- you are taking sedatives or tranquilizers
OTC - WHEN USING SECTION
When using this product
- do not use more than directed
- excitability may occur, especially in children
- marked drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
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.
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
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 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
- each packet contains: sodium 130 mg
- phenylketonurics: contains phenylalanine 41 mg per packet
- store between 20-25°C (68-77°F)
Inactive ingredients
anhydrous citric acid, aspartame, D&C Yellow #10, FD&C Red #40, flavors, saccharin sodium, sodium citrate, sucrose
Questions?
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
NDC 63824-110-08
NEW!
MAX Strength*
Delsym®
COUGH +™ COLD
NIGHT TIME
Acetaminophen (Pain Reliever/Fever Reducer)
Diphenhydramine HCl (Antihistamine/Cough Suppressant)
Phenylephrine HCl (Nasal Decongestant)
- Cough
- Nasal Congestion
- Sore Throat
- Body Aches
- Fever
HONEY LEMON
Flavored Mix
For Ages 12+
8 Packets
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Acetaminophen | ACTIVE INGREDIENT | 362O9ITL9D | 1 | |
| Diphenhydramine Hydrochloride | ACTIVE INGREDIENT | TC2D6JAD40 | 1 | |
| Phenylephrine Hydrochloride | ACTIVE INGREDIENT | 04JA59TNSJ | 1 | |
| Acetaminophen | ACTIVE MOIETY | 362O9ITL9D | 1 | |
| Diphenhydramine | ACTIVE MOIETY | 8GTS82S83M | 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 | |
| sodium citrate | INACTIVE INGREDIENT | 1Q73Q2JULR | 1 | |
| sucrose | INACTIVE INGREDIENT | C151H8M554 | 1 |
Products#
Every source-derived product name is available through these pages.
- Delsym Cough Plus Cold Night Time
- Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride
- Acetaminophen
- Diphenhydramine Hydrochloride
- Diphenhydramine
- Phenylephrine Hydrochloride
- Phenylephrine
- anhydrous citric acid
- aspartame
- D&C Yellow No. 10
- FD&C Red No. 40
- saccharin sodium
- SODIUM CITRATE, UNSPECIFIED FORM
- sucrose
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 63824-110 | 63824-110-08 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Acetaminophen | 362O9ITL9D | ACTIB |
| Diphenhydramine Hydrochloride | TC2D6JAD40 | 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 |
| SODIUM CITRATE, UNSPECIFIED FORM | 1Q73Q2JULR | IACT |
| sucrose | C151H8M554 | IACT |
Source Document#
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | SOLUTION / ORAL | 3900 mg | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, EXTENDED RELEASE / ORAL | 2.22 mg | ||
| saccharin sodium | SACCHARIN SODIUM | SB8ZUX40TY | PASTE / DENTAL | 0.3 %w/w | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | SHAMPOO / TOPICAL | 0.07 %w/w | ||
| sucrose | SUCROSE | C151H8M554 | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | 900 mg | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET / BUCCAL | 0.01 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION, SOLUTION / SUBCUTANEOUS | 25 mg | ||
| sucrose | SUCROSE | C151H8M554 | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | 18790 mg | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET / SUBLINGUAL | NA | ||
| D&C Yellow No. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | POWDER, FOR SUSPENSION / ORAL | 76 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | POWDER, FOR SOLUTION / ORAL | 123 mg | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | SPONGE / TOPICAL | NA | ||
| saccharin sodium | SACCHARIN SODIUM | SB8ZUX40TY | FILM, SOLUBLE / BUCCAL | 2 mg | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, EXTENDED RELEASE / ORAL | 1 mg | ||
| sucrose | SUCROSE | C151H8M554 | TABLET / BUCCAL | 109 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | LOZENGE / TRANSMUCOSAL | 44 mg | ||
| aspartame | ASPARTAME | Z0H242BBR1 | SUSPENSION / ORAL | 23 mg | ||
| sucrose | SUCROSE | C151H8M554 | SUPPOSITORY / RECTAL | NA | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION / INFILTRATION | 0.02 %w/v | ||
| sucrose | SUCROSE | C151H8M554 | GRANULE, FOR SUSPENSION / ORAL | 31885 mg | ||
| sucrose | SUCROSE | C151H8M554 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 119.12 mg | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | DROPS / ORAL | NA | ||
| sucrose | SUCROSE | C151H8M554 | LOZENGE / BUCCAL | NA | ||
| sucrose | SUCROSE | C151H8M554 | WAFER / ORAL | 155.2 mg | ||
| sucrose | SUCROSE | C151H8M554 | SYRUP / ORAL | 46400 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET / SUBLINGUAL | 36 mg | ||
| saccharin sodium | SACCHARIN SODIUM | SB8ZUX40TY | TABLET / ORAL | 43 mg | ||
| saccharin sodium | SACCHARIN SODIUM | SB8ZUX40TY | INJECTION / INTRAMUSCULAR | 22 mg | ||
| D&C Yellow No. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | GUM, CHEWING / ORAL | 2 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION / SUBCUTANEOUS | 101 mg | ||
| D&C Yellow No. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | GUM, CHEWING / BUCCAL | 24 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | GEL / TOPICAL | 3 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | SPRAY / TOPICAL | 0.01 %w/w | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 12 mg | ||
| sucrose | SUCROSE | C151H8M554 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS | 308 mg | ||
| aspartame | ASPARTAME | Z0H242BBR1 | TABLET, CHEWABLE / ORAL | 195 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET / BUCCAL | 30 mg | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE / ORAL | 16 mg | ||
| sucrose | SUCROSE | C151H8M554 | CAPSULE, COATED PELLETS / ORAL | 59.8 mg | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, COATED / ORAL | NA | ||
| saccharin sodium | SACCHARIN SODIUM | SB8ZUX40TY | INJECTION / INTRAVENOUS | 22 mg | ||
| D&C Yellow No. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | GEL / DENTAL | NA | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | SOLUTION / ORAL | 38 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION, SOLUTION / INTRAVENOUS | 772 mg | ||
| saccharin sodium | SACCHARIN SODIUM | SB8ZUX40TY | AEROSOL, METERED / RESPIRATORY (INHALATION) | 0.05 %w/w | ||
| D&C Yellow No. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | CAPSULE, EXTENDED RELEASE / ORAL | 3 mg | ||
| sucrose | SUCROSE | C151H8M554 | POWDER, FOR SUSPENSION / ORAL | 40017 mg | ||
| sucrose | SUCROSE | C151H8M554 | CONCENTRATE / ORAL | 4800 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | FILM, SOLUBLE / ORAL | 7 mg | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET / ORAL | 7 mg | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, COATED / ORAL | 0.1 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | CREAM / TOPICAL | 1 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | SPRAY / NASAL | 5 mg | ||
| D&C Yellow No. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | SOAP / TOPICAL | 1.4 %w/w | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, COATED PELLETS / ORAL | NA | ||
| sucrose | SUCROSE | C151H8M554 | INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS | 9.4 %w/v | ||
| sucrose | SUCROSE | C151H8M554 | INJECTABLE, LIPOSOMAL / INTRAVENOUS | 7560 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 35 mg | ||
| aspartame | ASPARTAME | Z0H242BBR1 | POWDER, FOR SUSPENSION / ORAL | 420 mg | ||
| aspartame | ASPARTAME | Z0H242BBR1 | GRANULE, FOR SUSPENSION / ORAL | 420 mg |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 00c9dfce-7f36-7ba7-e063-6294a90aeb4a | fd7d4722-4dc7-4427-8d6d-6470e8309c22 | 2023-07-18 | Warnings | fd7d4722-4dc7-4427-8d6d-6470e8309c22 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.