Indications and uses
temporarily relieves common cold/flu symptoms: nasal decongestion cough due to minor throat and bronchial irritation sore throat headache minor aches and pains fever
Day Time Gelcap
- Manufacturer
- Kareway Product, Inc.
- Effective date
- 2011-05-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:28:19
Label at a glance#
ProductDay Time Gelcap
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure8 sections
Dosage and administration
take only as directed-see Overdose warning do not exceed 4 doses per 24 hours adults and children 12 yrs and over 2 GelCaps with water every 6 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use
Label contents#
Full prescribing information#
Active ingredients(in each GelCap)
Acetaminophen 325mg
Dextromethorphan HBr 10mg
Phenylephrine HCl 5mg
Purpose
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Uses
temporarily relieves common cold/flu symptoms:
- nasal decongestion
- cough due to minor throat and bronchial irritation
- sore throat
- headache
- minor aches and pains
- fever
Warnings
Enter section text here
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4 doses in 24 hrs, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using this product
Sore throat warning:
If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see 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
- heart disease
- thyroid disease
- diabetes
- high blood pressure
- trouble urinating due to enlarged prostate gland
- cough that occurs with too much phegm(mucus)
- Persistent or chronic cough as occurs with smoking, asthma, emphysema
Ask a doctor or pharmacist before use if you are
taking the blood thinning drug warfarin.
When using this product, do not use more than directed
Stop use and ask a doctor if
- you get nervous, dizzy or sleepless
- symptoms get worse or last more than 5 days (children) or 7 days (adults)
- 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
Enter section text here
Overdose warning:
Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical to adults and children even if you do not notice any signs or symptoms.
Directions
- take only as directed-see Overdose warning
- do not exceed 4 doses per 24 hours
adults and children 12 yrs and over
2 GelCaps with water every 6 hrs
children 4 to under 12 yrs
ask a doctor
children under 4 yrs
do not use
Other information
- store at room temperature
Inactive ingredients
FDC red no. 40, FDC yellow no. 5, dioxide, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water and sobital special
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Daytime gelcap
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1086997 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | 1 |
| 1086997 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | 1 |
| 1086997 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SY | 1 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 67510-0523-0 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-c128-8e05-e053-dbdaa90a074a | Drug Facts |
| 67510-0523-1 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-c128-8e05-e053-dbdaa90a074a | Drug Facts |
| 67510-0523-2 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-c128-8e05-e053-dbdaa90a074a | Drug Facts |
| 67510-0523-4 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-c128-8e05-e053-dbdaa90a074a | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67510-0523-0 | Day Time Gelcap | 20 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 20 | 1 | |
| 67510-0523-0 | Day Time Gelcap | 2 in 1 BOX | CAPSULE, LIQUID FILLED | 2 | 1 | |
| 67510-0523-1 | Day Time Gelcap | 1 in 1 BOX | CAPSULE, LIQUID FILLED | 1 | 1 | |
| 67510-0523-1 | Day Time Gelcap | 10 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 10 | 1 | |
| 67510-0523-2 | Day Time Gelcap | 12 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 12 | 1 | |
| 67510-0523-2 | Day Time Gelcap | 1 in 1 BOX | CAPSULE, LIQUID FILLED | 1 | 1 | |
| 67510-0523-4 | Day Time Gelcap | 2 in 1 BOX | CAPSULE, LIQUID FILLED | 2 | 1 | |
| 67510-0523-4 | Day Time Gelcap | 24 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 24 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 67510-0523 | DAY TIME GELCAP (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) CAPSULE, LIQUID FILLED [KAREWAY PRODUCT, INC.] | 1 | Legacy NDC, 8 package rows | 20110616_4e73c368-e4eb-471e-aca4-fe551bde52bf.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 1 | |
| DEXTROMETHORPHAN HYDROBROMIDE | ACTIVE INGREDIENT | 9D2RTI9KYH | 1 | |
| PHENYLEPHRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 04JA59TNSJ | 1 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 1 | |
| DEXTROMETHORPHAN | ACTIVE MOIETY | 7355X3ROTS | 1 | |
| PHENYLEPHRINE | ACTIVE MOIETY | 1WS297W6MV | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 1 | |
| FD&C YELLOW NO. 5 | INACTIVE INGREDIENT | I753WB2F1M | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | 1 | |
| PROPYLENE GLYCOL, (R)- | INACTIVE INGREDIENT | 602HN5L69H | 1 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- Day Time Gelcap
- Acetaminophen, Dextromethorphan, Phenylephrine
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- FD&C RED NO. 40
- FD&C YELLOW NO. 5
- GELATIN
- GLYCERIN
- POLYETHYLENE GLYCOL
- POVIDONE
- PROPYLENE GLYCOL, (R)-
- WATER
- SORBITOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 67510-0523 | 67510-0523-1, 67510-0523-2, 67510-0523-0, 67510-0523-4 |
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 |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| FD&C YELLOW NO. 5 | I753WB2F1M | IACT |
| GELATIN | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYETHYLENE GLYCOL | 3WJQ0SDW1A | IACT |
| POVIDONE | FZ989GH94E | IACT |
| PROPYLENE GLYCOL, (R)- | 602HN5L69H | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITOL | 506T60A25R | 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 |
|---|---|---|---|---|---|---|
| GELATIN | GELATIN | 2G86QN327L | TABLET, COATED / ORAL | 42.12 mg | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR | 2 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | POWDER, FOR SUSPENSION / ORAL | 35 mg/5ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / TRANSDERMAL | 306.2 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | CONCENTRATE / ORAL | 600 mg/1ml | ||
| GELATIN | GELATIN | 2G86QN327L | DROPS / NASAL | 50 mg/1ml | ||
| POVIDONE | POVIDONE | FZ989GH94E | SUSPENSION / OPHTHALMIC | 1.8 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, EXTENDED RELEASE / ORAL | 7 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, DELAYED RELEASE / ORAL | 0.01 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET, FILM COATED / ORAL | 240 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SYRUP / ORAL | 3 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | TROCHE / ORAL | 30 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SOLUTION / DENTAL | NA | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, ORALLY DISINTEGRATING / ORAL | 7 mg | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | CONCENTRATE / BUCCAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / AURICULAR (OTIC) | 63.64 %w/v | ||
| SORBITOL | SORBITOL | 506T60A25R | SOLUTION / OPHTHALMIC | 6 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / INTRALESIONAL | 45 %w/v | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE, COATED / ORAL | 288 mg | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE, DELAYED RELEASE / ORAL | 1791 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYSTEM / IONTOPHORESIS | 168.1 mg | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION / INTRACAVITARY | 0.05 ml | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | ELIXIR / ORAL | 12.5 mg/5ml | ||
| SORBITOL | SORBITOL | 506T60A25R | SOLUTION / ORAL | 29268 mg | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION, SUSPENSION / INTRAMUSCULAR | 1.3 mg | ||
| GELATIN | GELATIN | 2G86QN327L | PASTE / DENTAL | 252 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | CAPSULE / ORAL | 300 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | LIQUID / ORAL | 53460 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CONCENTRATE / ORAL | 1800 mg | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | TABLET, CHEWABLE / ORAL | 4.5 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SHAMPOO / TOPICAL | 2 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / OPHTHALMIC | 2.5 %w/v | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SPONGE / TOPICAL | NA | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, COATED PELLETS / ORAL | NA | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET / BUCCAL | 0.01 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | POWDER, FOR SUSPENSION / ORAL | 3 mg | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET, ORALLY DISINTEGRATING / SUBLINGUAL | 13 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET, COATED / ORAL | 49.2 mg | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | SOLUTION / ORAL | 1 mg/1ml | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS | 14 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | PASTE / DENTAL | 14.6 %w/w | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | DROPS / ORAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE, DENTIFRICE / DENTAL | 18 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / AURICULAR (OTIC) | 0.05 %w/w | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE / ORAL | 16 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LIQUID / ORAL | 2400 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LIQUID / TOPICAL | 2.5 %w/w | ||
| SORBITOL | SORBITOL | 506T60A25R | GUM, CHEWING / BUCCAL | 5110 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPONGE / TOPICAL | 2 %w/w | ||
| GELATIN | GELATIN | 2G86QN327L | DROPS / ORAL | NA | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR | 1 mg | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET, CHEWABLE / ORAL | 24 mg | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET / SUBLINGUAL | 19 mg | ||
| GELATIN | GELATIN | 2G86QN327L | SOLUTION / INTRAVENOUS | 34.8 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | POWDER, FOR SUSPENSION / ORAL | 12000 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYSTEM / TOPICAL | 18144 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / BUCCAL | 34 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SUSPENSION/ DROPS / ORAL | 1 mg | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / SUBCUTANEOUS | 4.7 %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 |
|---|---|---|---|---|---|---|
| 57c0ea57-c0f3-48e1-a8bd-834047b7f839 | 4e73c368-e4eb-471e-aca4-fe551bde52bf | 2011-05-09 | Warnings | 57c0ea57-c0f3-48e1-a8bd-834047b7f839 4e73c368-e4eb-471e-aca4-fe551bde52bf |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.