Indications and uses
temporarily relieves common cold and flu symptoms: minor aches and pains headache sore throat nasal congestion fever cough due to minor throat and bronchial irritation
Daytime
- Manufacturer
- Good Sense (Geiss, Destin & Dunn, Inc.)
- Effective date
- 2022-10-28
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 7
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:50:21
Label at a glance#
ProductDaytime
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections
Dosage and administration
do not take more than directed (see Overdose warning) do not take more than 4 doses in 24 hours adults and children 12 years and over: take 2 softgels with water every 4 hours swallow whole; do not crush, chew, or dissolve children under 12 years: do not use when using other Daytime or Nighttime products, carefully read each label to insure correct dosing
Contacts and useful links#
Websitewww.valuelabels.com
www.valuelabels.com
www.valuelabels.comLabel contents#
Full prescribing information#
Active ingredients (in each softgel)
Acetaminophen 325 mg
Dextromethoprhan HBr 10 mg
Phenlyephrine HCl 5 mg
Purpose
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Uses
- temporarily relieves common cold and flu symptoms:
- minor aches and pains
- headache
- sore throat
- nasal congestion
- fever
- cough due to minor throat and bronchial irritation
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
- 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
- diabetes
- heart disease
- thyroid disease
- high blood pressure
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- cough that occurs with too much phlegm (mucus)
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
- pain, cough, or nasal congestion gets worse or lasts more than 7 days
- nervousness, dizziness, or sleeplessness occur
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- 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: Taking more than the recommended dose can 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 4 doses in 24 hours
- adults and children 12 years and over: take 2 softgels with water every 4 hours
- swallow whole; do not crush, chew, or dissolve
- children under 12 years: do not use
- when using other Daytime or Nighttime products, carefully read each label to insure correct dosing
Other information
- store between 15-30ºC (59-86ºF)
- avoid excessive heat
Inactive ingredients
butylated hydroxyanisole*, butylated hydroxytoluene*, carminic acid*, edible white ink, D&C yellow #10*, FD&C red #40, FD&C yellow#6, gelatin, glycerin, polyethylene glycol*, povidone, propylene glycol, purified water, sodium metabisulfite*, sorbitan*, sorbitol
*contains one or more of these ingredients
Questions or comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Pseudoephedrine free formula
Daytime
Acetaminophen
Dextromethorphan HBr, Phenylephrine HCl
- pain reliever
- fever reducer
- cough suppressant
- nasal decongestant
Alcohol free
Antihistamine free
Softgels**
(**Liquid filled capsules)
Non drowsy cold/flu relief
†Compare to active ingredients in Vicks® DayQuil® LiquidCaps®
†This product is not manufactured or distributed by The Procter & Gamble Company. Vicks®, DayQuil®, and LiquiCaps® are registered trademarks of the Procter & Gamble Company.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
Distributed by:
Geiss, Destin & Dunn, Inc.
Peachtree City, GA 30269
Package Label
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50804-468-16 | 2021-10-15 | C162847 | 48780-1 | ba0f9c33-2b15-a910-e053-dadaa90a0b85 | Drug Facts |
| 50804-468-24 | 2021-10-15 | C162847 | 48780-1 | ba0f9c33-2b15-a910-e053-dadaa90a0b85 | Drug Facts |
| 50804-468-16 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-2b15-a910-e053-dadaa90a0b85 | Drug Facts |
| 50804-468-24 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-2b15-a910-e053-dadaa90a0b85 | Drug Facts |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50804-468-16 | EA - Each | 50804-468 | 9794fc01-2335-40ef-b1ce-8da2c06add3e | 1 | 2017-08-11 |
| 50804-468-24 | EA - Each | 50804-468 | 2b608033-fab5-461e-8e27-7efedc4f2b06 | 1 | 2017-08-11 |
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 | |
| BUTYLATED HYDROXYANISOLE | INACTIVE INGREDIENT | REK4960K2U | 2 | |
| BUTYLATED HYDROXYTOLUENE | INACTIVE INGREDIENT | 1P9D0Z171K | 2 | |
| CARMINIC ACID | INACTIVE INGREDIENT | CID8Z8N95N | 2 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | 2 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 2 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | 2 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | 2 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 2 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | 2 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 2 | |
| SODIUM METABISULFITE | INACTIVE INGREDIENT | 4VON5FNS3C | 2 | |
| SORBITAN | INACTIVE INGREDIENT | 6O92ICV9RU | 2 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 2 |
Products#
Every source-derived product name is available through these pages.
- Daytime
- ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- BUTYLATED HYDROXYANISOLE
- BUTYLATED HYDROXYTOLUENE
- FD&C RED NO. 40
- FD&C YELLOW NO. 6
- GELATIN
- GLYCERIN
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POVIDONE
- PROPYLENE GLYCOL
- WATER
- SORBITAN
- SORBITOL
- CARMINIC ACID
- D&C YELLOW NO. 10
- SODIUM METABISULFITE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50804-468 | 50804-468-16, 50804-468-24 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| SODIUM METABISULFITE | SODIUM METABISULFITE | 4VON5FNS3C | SUSPENSION / ORAL | 40 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | GEL / TOPICAL | 8 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION / INTRAMUSCULAR | 7459 mg | ||
| SODIUM METABISULFITE | SODIUM METABISULFITE | 4VON5FNS3C | INJECTION / PERINEURAL | 0.05 %w/v | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE, COATED / ORAL | 288 mg | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET, CHEWABLE / ORAL | 24 mg | ||
| SODIUM METABISULFITE | SODIUM METABISULFITE | 4VON5FNS3C | INJECTION, SOLUTION / INFILTRATION | 0.05 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / TRANSDERMAL | 306.2 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SOAP / TOPICAL | 0.2 %w/w | ||
| POVIDONES | POVIDONE | FZ989GH94E | CAPSULE, DELAYED RELEASE / ORAL | NA | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET / SUBLINGUAL | NA | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET, CHEWABLE / ORAL | 48 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM, AUGMENTED / TOPICAL | 8 %w/w | ||
| SODIUM METABISULFITE | SODIUM METABISULFITE | 4VON5FNS3C | SYRUP / ORAL | 80 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SHAMPOO / TOPICAL | 8 %w/w | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | CAPSULE, DELAYED RELEASE / ORAL | 1 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | CAPSULE, EXTENDED RELEASE / ORAL | 56 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / OPHTHALMIC | 58 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | POWDER, FOR SOLUTION / ORAL | 40 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | GEL / TOPICAL | NA | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 0.02 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SPRAY, METERED / NASAL | 240 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SOLUTION / RECTAL | 0.5 %w/v | ||
| SORBITOL | SORBITOL | 506T60A25R | SYRUP / ORAL | 4370 mg/5ml | ||
| GELATIN | GELATIN | 2G86QN327L | GUM, CHEWING / BUCCAL | 102 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | SOLUTION / OPHTHALMIC | 1.8 %w/v | ||
| SORBITAN | SORBITAN | 6O92ICV9RU | CAPSULE, LIQUID FILLED / ORAL | NA | ||
| POVIDONES | POVIDONE | FZ989GH94E | SOLUTION / ORAL | 3000 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, EXTENDED RELEASE / ORAL | 428 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | SUSPENSION / ORAL | 2.5 mg/5ml | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SOLUTION, CONCENTRATE / ORAL | 0.1 mg/1ml | ||
| SODIUM METABISULFITE | SODIUM METABISULFITE | 4VON5FNS3C | CAPSULE / ORAL | 0.36 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | INJECTION, SOLUTION / INTRAVENOUS | NA | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SPRAY / TOPICAL | 3 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, EXTENDED RELEASE / ORAL | 9 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | ELIXIR / ORAL | 0.3 mg/15ml | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | TABLET, ORALLY DISINTEGRATING / ORAL | 2 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | SYRUP / ORAL | 1 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | GRANULE, FOR SUSPENSION / ORAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / VAGINAL | 750 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | LOTION / TOPICAL | 10.7 %w/w | ||
| SORBITAN | SORBITAN | 6O92ICV9RU | ELIXIR / ORAL | 0.6 ml/15ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYSTEM / TOPICAL | 18144 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | TABLET, FILM COATED / ORAL | 0.4 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, ORALLY DISINTEGRATING / ORAL | 12 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | TABLET / ORAL | 80 mg | ||
| SORBITAN | SORBITAN | 6O92ICV9RU | CAPSULE / ORAL | 19.08 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SPONGE / TOPICAL | 40 %w/w | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET / SUBLINGUAL | 50.5 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | ELIXIR / ORAL | 9306 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET / ORAL | 337.28 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | CREAM / VAGINAL | 0.05 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SUSPENSION / SUBCUTANEOUS | 1.6 %w/v | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION, SUSPENSION / INTRAMUSCULAR | 1.3 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SYRUP / ORAL | 4 mg/5ml | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | TABLET, FOR SUSPENSION / ORAL | 0.1 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | LOTION / TOPICAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / AURICULAR (OTIC) | 56.55 %w/v | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET, FILM COATED / ORAL | 240 mg | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET, ORALLY DISINTEGRATING / ORAL | 120 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 |
|---|---|---|---|---|---|---|
| 54ddfe02-4885-42d0-8f53-3456375824ae | 2d693d10-75ad-406c-bc0c-b1c47a713870 | 2022-10-28 | Warnings | 54ddfe02-4885-42d0-8f53-3456375824ae 2d693d10-75ad-406c-bc0c-b1c47a713870 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.