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 Cold/Flu Relief
- Manufacturer
- Kareway Product, Inc.
- Effective date
- 2012-07-11
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-05-31 22:32:33
Label at a glance#
ProductDay Time Cold/Flu Relief
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure8 sections
Dosage and administration
take only as directed-see Overdose warning use dose cup or tablespoon (TBSP) do not exceed 4 doses per 24 hours adults and children 12 yrs and over 30 ml (2 TBSP) every 6 hours children 6 to under 12 yrs 15 ml (1 TBSP) every 4 hours children 4 to under 6 yrs ask a doctor children under 4 yrs do not use
Label contents#
Full prescribing information#
Active ingredients(in each 15 ml tablespoon)
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 adult/child takes
- more than 4 doses in 24 hrs, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks every day 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
- 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 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 for adults and children even if you do not notice any signs or symptoms.
Directions
- take only as directed-see Overdose warning
- use dose cup or tablespoon (TBSP)
- do not exceed 4 doses per 24 hours
adults and children 12 yrs and over
30 ml (2 TBSP) every 6 hours
children 6 to under 12 yrs
15 ml (1 TBSP) every 4 hours
children 4 to under 6 yrs
ask a doctor
children under 4 yrs
do not use
Other information
- each tablespoon contains: sodium 50mg
- store at room temperature
Inactive ingredients
citric acid, FDC red no.40, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium,
sodium citrate, sucralose, sucrose, xanthan gum
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Daytime Cold/Flu Relief
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1113705 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution | PSN | 3 |
| 1113705 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | 3 |
| 1113705 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | 3 |
| 1113705 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | 3 |
| 1113705 | APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SY | 3 |
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 |
|---|---|---|---|---|---|
| 67510-0544-0 | 2019-11-13 | C162847 | 48780-1 | 97449f38-d52f-f6ea-e053-dbdaa90aa703 | Drug Facts |
| 67510-0544-2 | 2019-11-13 | C162847 | 48780-1 | 97449f38-d52f-f6ea-e053-dbdaa90aa703 | Drug Facts |
| 67510-0544-4 | 2019-11-13 | C162847 | 48780-1 | 97449f38-d52f-f6ea-e053-dbdaa90aa703 | Drug Facts |
| 67510-0544-6 | 2019-11-13 | C162847 | 48780-1 | 97449f38-d52f-f6ea-e053-dbdaa90aa703 | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67510-0544-0 | Day Time Cold/Flu Relief | 295 mL in 1 BOTTLE | LIQUID | 295 | 3 | |
| 67510-0544-2 | Day Time Cold/Flu Relief | 354 mL in 1 BOTTLE | LIQUID | 354 | 3 | |
| 67510-0544-4 | Day Time Cold/Flu Relief | 120 mL in 1 BOTTLE | LIQUID | 120 | 3 | |
| 67510-0544-6 | Day Time Cold/Flu Relief | 177 mL in 1 BOTTLE | LIQUID | 177 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 67510-0544 | DAY TIME COLD/FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) LIQUID [KAREWAY PRODUCT, INC.] | 3 | Legacy NDC, 4 package rows | 20120713_28880f80-5d05-40a7-aaf0-0563c6f68c3a.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 3 | |
| DEXTROMETHORPHAN HYDROBROMIDE | ACTIVE INGREDIENT | 9D2RTI9KYH | 3 | |
| PHENYLEPHRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 04JA59TNSJ | 3 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 3 | |
| DEXTROMETHORPHAN | ACTIVE MOIETY | 7355X3ROTS | 3 | |
| PHENYLEPHRINE | ACTIVE MOIETY | 1WS297W6MV | 3 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | 3 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 3 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 3 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | 3 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 3 | |
| SACCHARIN SODIUM DIHYDRATE | INACTIVE INGREDIENT | SB8ZUX40TY | 3 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | 3 | |
| SUCRALOSE | INACTIVE INGREDIENT | 96K6UQ3ZD4 | 3 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | 3 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 3 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | 3 |
Products#
Every source-derived product name is available through these pages.
- Day Time Cold/Flu Relief
- Acetaminophen, Dextromethorphan, Phenylephrine
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- CITRIC ACID MONOHYDRATE
- FD&C RED NO. 40
- GLYCERIN
- POLYETHYLENE GLYCOLS
- PROPYLENE GLYCOL
- WATER
- SODIUM CITRATE
- SUCROSE
- SUCRALOSE
- SACCHARIN SODIUM DIHYDRATE
- XANTHAN GUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 67510-0544 | 67510-0544-4, 67510-0544-6, 67510-0544-0, 67510-0544-2 |
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 |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYETHYLENE GLYCOLS | 3WJQ0SDW1A | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| SUCROSE | C151H8M554 | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| SACCHARIN SODIUM DIHYDRATE | SB8ZUX40TY | IACT |
| XANTHAN GUM | TTV12P4NEE | 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 |
|---|---|---|---|---|---|---|
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET / ORAL | 42 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 2 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | FILM, EXTENDED RELEASE / TRANSDERMAL | 58.13 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE / ORAL | 3568 mg | ||
| SACCHARIN SODIUM DIHYDRATE | SACCHARIN SODIUM | SB8ZUX40TY | GEL / DENTAL | 0.3 %w/w | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SPRAY / NASAL | 9 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SUSPENSION / ORAL | 48209 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / RECTAL | 3315 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | SPRAY / NASAL | 2 mg | ||
| SACCHARIN SODIUM DIHYDRATE | SACCHARIN SODIUM | SB8ZUX40TY | WAFER / ORAL | 8 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / VAGINAL | 6.4 %w/w | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | POWDER, FOR SOLUTION / ORAL | 0.33 mg/5ml | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | LIQUID / ORAL | 114 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, DELAYED RELEASE / ORAL | 36 mg | ||
| SACCHARIN SODIUM DIHYDRATE | SACCHARIN SODIUM | SB8ZUX40TY | SYRUP / ORAL | 24 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | FILM / ORAL | 1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | OINTMENT / TOPICAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | EMULSION / OPHTHALMIC | 1.5 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / OPHTHALMIC | 6 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM / VAGINAL | 1225 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, COATED / ORAL | NA | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET, COATED / ORAL | NA | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SOLUTION / ORAL | 84 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / SUBCUTANEOUS | 15 %w/v | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SUSPENSION / ORAL | 100 mg/5ml | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTABLE, LIPOSOMAL / INTRAVENOUS | 7560 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | AEROSOL / TOPICAL | 3 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / ORAL | 750 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | DROPS / ORAL | NA | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 6 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS | 308 mg | ||
| SACCHARIN SODIUM DIHYDRATE | SACCHARIN SODIUM | SB8ZUX40TY | OINTMENT / DENTAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, FILM COATED / ORAL | 1.55 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | 18790 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LOTION / TOPICAL | 3990 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | GUM, CHEWING / BUCCAL | 48 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SUSPENSION / TOPICAL | 0.11 %w/v | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SUSPENSION / OPHTHALMIC | ADJ PH | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / DENTAL | 15 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, SOLUTION / INTRAMUSCULAR | 4000 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / SUBCUTANEOUS | 28 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / TRANSDERMAL | 500 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / OPHTHALMIC | 1 %w/v | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE, COATED PELLETS / ORAL | 59.8 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | LIQUID / ORAL | 29008 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SUSPENSION, EXTENDED RELEASE / ORAL | 186.8 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION / SUBCUTANEOUS | 1.4 %w/v | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC | 0.6 %w/w | ||
| SUCROSE | SUCROSE | C151H8M554 | POWDER / ORAL | 27768 mg | ||
| SACCHARIN SODIUM DIHYDRATE | SACCHARIN SODIUM | SB8ZUX40TY | PASTE / DENTAL | 0.3 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | EMULSION / INTRAVENOUS | 2.2 %w/v | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, DELAYED RELEASE / ORAL | 2 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / AURICULAR (OTIC) | 25 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION / INTRAVENOUS | 1950 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 19 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / EPIDURAL | 0.02 %w/v | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 38 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SYRUP / ORAL | 46400 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET, FOR SUSPENSION / ORAL | 65 mg | ||
| SACCHARIN SODIUM DIHYDRATE | SACCHARIN SODIUM | SB8ZUX40TY | SOLUTION / RESPIRATORY (INHALATION) | NA |
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 |
|---|---|---|---|---|---|---|
| f32e3302-f170-4be8-a351-8b383d43052d | 28880f80-5d05-40a7-aaf0-0563c6f68c3a | 2012-07-11 | Warnings | f32e3302-f170-4be8-a351-8b383d43052d 28880f80-5d05-40a7-aaf0-0563c6f68c3a |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.