Indications and uses
• temporarily relieves these symptoms due to a cold: • minor aches and pains • minor sore throat pain • headache • nasal and sinus congestion • cough due to minor throat and bronchial irritation • temporarily reduces fever
healthy accents severe cold
- Manufacturer
- DZA Brands LLC
- Effective date
- 2019-08-23
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:14:30
Label at a glance#
Producthealthy accents severe cold daytime
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections
Dosage and administration
• do not use more than directed (see overdose warning) • take every 4 hours, while symptoms persist. Do not take more than 5 packets in 24 hours unless directed by a doctor. Age Dose adults and children 12 years of age and over one packet children under 12 years of age do not use • dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10-15 minutes. • if using a microwave...
Storage and handling
• each packet contains: potassium 5 mg and sodium 43 mg • phenylketonurics: contains phenylalanine 17 mg per packet • store at 20-25 ° C (68-77 ° F). Protect product from heat and moisture.
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredients (in each packet)
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Phenylephrine HCl 10 mg
Purposes
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Uses
- temporarily relieves these symptoms due to a cold:
- minor aches and pains
- minor sore throat pain
- headache
- nasal and sinus congestion
- cough due to minor throat and bronchial irritation
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
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: 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
- in a child under 12 years of age
- if you have ever had an allergic reaction to this product or any of its ingredients
- 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
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema
- a sodium-restricted diet
Ask a doctor or pharmacist before use if you are
taking the blood thinning drug warfarin
When using this product
do not exceed recommended dosage
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occurs
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- pain, cough or nasal congestion gets worse or lasts more than 7 days
- cough comes back or occurs with rash or headache that lasts.
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: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- do not use more than directed (see overdose warning)
- take every 4 hours, while symptoms persist. Do not take more than 5 packets in 24 hours unless directed by a doctor.
Age | Dose |
adults and children 12 years of age and over | one packet |
children under 12 years of age | do not use |
- dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10-15 minutes.
- if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat.
Other information
- each packet contains: potassium 5 mg and sodium 43 mg
- phenylketonurics: contains phenylalanine 17 mg per packet
- store at 20-25°C (68-77°F). Protect product from heat and moisture.
Inactive ingredients
acesulfame potassium, anhydrous citric acid, aspartame, colloidal silicon dioxide, FD&C blue #1, FD&C red #40, flavor, maltodextrin, pregelatinized starch, sodium citrate, sucrose, tribasic calcium phosphate
Questions or comments?
1-866-322-2439
Package/Label Principal Display Panel
daytime
severe cold cough & flu
acetaminophen – pain reliever/fever reducer
dextromethorphan HBr
cough suppressant
phenylephrine HCl
nasal decongestant
nasal & sinus congestion
cough
body ache
sore throat pain
headache
fever
Compare to Theraflu® Daytime Severe Cold & Cough active ingredients
6 packets
NO GLUTEN
berry infused with menthol flavor
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 2 | |
| DEXTROMETHORPHAN HYDROBROMIDE | ACTIVE INGREDIENT | 9D2RTI9KYH | 2 | |
| PHENYLEPHRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 04JA59TNSJ | 2 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 2 | |
| DEXTROMETHORPHAN | ACTIVE MOIETY | 7355X3ROTS | 2 | |
| PHENYLEPHRINE | ACTIVE MOIETY | 1WS297W6MV | 2 | |
| ACESULFAME POTASSIUM | INACTIVE INGREDIENT | 23OV73Q5G9 | 2 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | 2 | |
| ASPARTAME | INACTIVE INGREDIENT | Z0H242BBR1 | 2 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 2 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 2 | |
| MALTODEXTRIN | INACTIVE INGREDIENT | 7CVR7L4A2D | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 2 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | 2 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | 2 | |
| TRIBASIC CALCIUM PHOSPHATE | INACTIVE INGREDIENT | 91D9GV0Z28 | 2 |
Products#
Every source-derived product name is available through these pages.
- healthy accents severe cold daytime
- Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- ACESULFAME POTASSIUM
- ANHYDROUS CITRIC ACID
- ASPARTAME
- SILICON DIOXIDE
- FD&C BLUE NO. 1
- FD&C RED NO. 40
- MALTODEXTRIN
- SUCROSE
- TRIBASIC CALCIUM PHOSPHATE
- SODIUM CITRATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55316-096 | 55316-096-91 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| ACESULFAME POTASSIUM | 23OV73Q5G9 | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| ASPARTAME | Z0H242BBR1 | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| MALTODEXTRIN | 7CVR7L4A2D | IACT |
| SUCROSE | C151H8M554 | IACT |
| TRIBASIC CALCIUM PHOSPHATE | 91D9GV0Z28 | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | 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 |
|---|---|---|---|---|---|---|
| SUCROSE | SUCROSE | C151H8M554 | POWDER, FOR SUSPENSION / ORAL | 40017 mg | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | LOZENGE / ORAL | 175 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | TABLET, FOR SUSPENSION / ORAL | 15 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | PASTE / DENTAL | 34 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SUSPENSION / ORAL | 400 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, EXTENDED RELEASE / ORAL | 284.54 mg | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | TABLET / ORAL | 320 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | GRANULE, EFFERVESCENT / ORAL | 30 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | GRANULE / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SUSPENSION / ORAL | 2553 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SUPPOSITORY / RECTAL | 14 mg | ||
| ACESULFAME POTASSIUM | ACESULFAME POTASSIUM | 23OV73Q5G9 | POWDER, FOR SUSPENSION / ORAL | 45 mg/5ml | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SUSPENSION / ORAL | 400 mg | ||
| TRIBASIC CALCIUM PHOSPHATE | TRIBASIC CALCIUM PHOSPHATE | 91D9GV0Z28 | CAPSULE, EXTENDED RELEASE / ORAL | 32.73 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, EXTENDED RELEASE / ORAL | 450 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SYRUP / ORAL | 268 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET / SUBLINGUAL | 109 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | PASTILLE / ORAL | 426 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | POWDER, FOR SUSPENSION / ORAL | 1 mg/5ml | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SPRAY / NASAL | 5 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SUSPENSION, EXTENDED RELEASE / ORAL | 5400 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET / ORAL | 197 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER / ORAL | 602 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, EXTENDED RELEASE / ORAL | 1 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | DROPS / ORAL | NA | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | CONCENTRATE / INTRAVENOUS | ADJ PH | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE / ORAL | 3568 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SUSPENSION / RESPIRATORY (INHALATION) | 1 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 2 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | FILM, EXTENDED RELEASE / BUCCAL | 1 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, FILM COATED / ORAL | 0.16 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SYRUP / ORAL | 3 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET, EFFERVESCENT / ORAL | 840 mg | ||
| ACESULFAME POTASSIUM | ACESULFAME POTASSIUM | 23OV73Q5G9 | SOLUTION / DENTAL | 0.12 %w/w | ||
| SUCROSE | SUCROSE | C151H8M554 | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | 18790 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SHAMPOO / TOPICAL | 2 mg | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | LOZENGE / ORAL | 120 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, COATED / ORAL | 0.1 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | NA | ||
| SUCROSE | SUCROSE | C151H8M554 | DROPS / ORAL | NA | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | AEROSOL / TOPICAL | 0.08 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CREAM / VAGINAL | 51 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | WAFER / ORAL | 155.2 mg | ||
| ACESULFAME POTASSIUM | ACESULFAME POTASSIUM | 23OV73Q5G9 | LOZENGE / ORAL | 120 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | POWDER, FOR SUSPENSION / ORAL | 420 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION / SUBCUTANEOUS | 101 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SUSPENSION / ORAL | 1 mg | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | PASTE / ORAL | 1050 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | POWDER, FOR SOLUTION / ORAL | 123 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 119.12 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | PASTE / DENTAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | INSERT / VAGINAL | 8 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 0.02 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET / BUCCAL | 109 mg | ||
| ACESULFAME POTASSIUM | ACESULFAME POTASSIUM | 23OV73Q5G9 | TABLET, EFFERVESCENT / ORAL | 4 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | POWDER, FOR SOLUTION / ORAL | 233 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | GRANULE, FOR SOLUTION / ORAL | 42596 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SOLUTION / TOPICAL | 4.35 %w/v |
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 |
|---|---|---|---|---|---|---|
| 9902cdf8-0b4e-4a0f-8857-bbecaff21dce | 858a597c-15ea-49aa-b35b-0cbdf4bd7f9f | 2021-01-08 | Warnings | 858a597c-15ea-49aa-b35b-0cbdf4bd7f9f |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.