Indications and uses
temporarily relieves common cold/flu symptoms: minor aches and pains headache sore throat fever nasal congestion cough due to minor throat and bronchial irritation
Cold and Flu
- Manufacturer
- Freds Inc
- Effective date
- 2023-11-28
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:19:52
Label at a glance#
ProductCold and Flu Daytime Relief
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 any 24-hour period measure only with dosing cup provided. Do not use any other dosing device keep dosing cup with product mL=milliliter adults and children 12 years and over 30 mL every 4 hours children 6 to under 12 years 15 mL every 4 hours children 4 to under 6 years ask a doctor children under 4 years do not use When ...
Contacts and useful links#
Websitewww.fredsinc.com
www.fredsinc.com
www.fredsinc.comLabel contents#
Full prescribing information#
Active ingredients (in each 15 mL)
Acetaminophen 325 mg
Dextromethoprhan HBr 10 mg
Phenlyephrine HCl 5 mg
Purposes
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Uses
- temporarily relieves common cold/flu symptoms:
- minor aches and pains
- headache
- sore throat
- fever
- nasal congestion
- cough due to minor throat and bronchial irritation
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
- adult takes more than 4 doses (30 mL each) of acetaminophen in 24 hours, which is the maximum daily amount
- child takes more than 4 doses (15 mL each) in 24 hours
- taken with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks every day while using this product
Allery 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
- 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.
- with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Ask a doctor before use if you have
- liver disease
- heart disease
- thyroid disease
- diabetes
- high blood pressure
- a sodium-restricted diet
- persistent or chronic cough such as occurs with smoking, asthma or emphysema
- cough that occurs with too much phlegm (mucus)
- trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if the user is
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
- pain, nasal congestion or cough gets worse or lasts 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.
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 (1-800-222-1222) 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 any 24-hour period
- measure only with dosing cup provided. Do not use any other dosing device
- keep dosing cup with product
- mL=milliliter
| adults and children 12 years and over | 30 mL every 4 hours |
| children 6 to under 12 years | 15 mL every 4 hours |
| children 4 to under 6 years | ask a doctor |
| children under 4 years | do not use |
- When using Day Time and Night Time products, carefully read each label to ensure correct dosing
Other information
- each 15 mL contains: sodium 12 mg
- store between 20-25ºC (68-77ºF)
- do not refrigerate
Inactive ingredients
citric acid, FD&C yellow #6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, xanthan gum
Questions or comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Compare to the active ingredients in Vicks® DayQuil® Cold & Flu*
DAYTIME RELIEF
Cold & Flu
Each dose (per 15 mL) of oral solution contains:
325 mg- Acetaminophen (Pain reliever/fever reducer)
10 mg- Dextromethorphan HBr (cough suppressant)
Phenylephrine HCl (Nasal decongestant)
- aches, fever and sore throat
- nasal congeston
- cough
Non-Drowsy • Multi-Symptom
Alcohol-Free • Antihistamine-Free
FL OZ (mL)
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.
*This product is not manufactured or distributed by The Procter & Gamble Company.Vicks® and DayQuil® are registered trademarks of The Procter & Gamble Company.
DISTRIBUTED BY: fred's Inc
4300 NEW GETWELL RD, MEMPHIS, TN 38118
Package Label
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55315-066-12 | 2023-01-30 | C162847 | 48780-1 | d6a99b39-eba8-a426-e053-dadaa90af4c2 | Drug Facts |
| 55315-066-12 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-eba8-a426-e053-dadaa90af4c2 | Drug Facts |
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 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | 1 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | 1 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | 1 | |
| SUCRALOSE | INACTIVE INGREDIENT | 96K6UQ3ZD4 | 1 | |
| TRISODIUM CITRATE DIHYDRATE | INACTIVE INGREDIENT | B22547B95K | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | 1 |
Products#
Every source-derived product name is available through these pages.
- Cold and Flu Daytime Relief
- Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- ANHYDROUS CITRIC ACID
- FD&C YELLOW NO. 6
- GLYCERIN
- PROPYLENE GLYCOL
- WATER
- SACCHARIN SODIUM
- TRISODIUM CITRATE DIHYDRATE
- SODIUM BENZOATE
- SODIUM CHLORIDE
- SORBITOL
- SUCRALOSE
- XANTHAN GUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55315-066 | 55315-066-12 |
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 |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| TRISODIUM CITRATE DIHYDRATE | B22547B95K | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SODIUM CHLORIDE | 451W47IQ8X | IACT |
| SORBITOL | 506T60A25R | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | 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 |
|---|---|---|---|---|---|---|
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | GEL / TOPICAL | 5 mg | ||
| TRISODIUM CITRATE DIHYDRATE | TRISODIUM CITRATE DIHYDRATE | B22547B95K | POWDER, FOR SUSPENSION / ORAL | 5010 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SYSTEM / TOPICAL | 3.1 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CLOTH / TOPICAL | 0.03 mg/mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | POWDER / ORAL | 20 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | EMULSION / TOPICAL | 8 %w/w | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | CAPSULE, LIQUID FILLED / ORAL | 360 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, FILM COATED / ORAL | 96 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | PASTE / ORAL | 28 mg | ||
| TRISODIUM CITRATE DIHYDRATE | TRISODIUM CITRATE DIHYDRATE | B22547B95K | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 800 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / INTRAVENOUS | 90 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / ORAL | 148 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / EPIDURAL | 3535 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRACARDIAC | 70 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / SUBCUTANEOUS | 4.7 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / PERIDURAL | 8.07 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | EMULSION / TOPICAL | 7 %w/w | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 2922 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | CAPSULE / ORAL | 1111 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / RETROBULBAR | 648 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SYRUP / ORAL | 5700 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION, CONCENTRATE / SUBCUTANEOUS | 0.86 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / SUBCUTANEOUS | 450 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / OPHTHALMIC | 0.88 %w/w | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION / OPHTHALMIC | 10 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / PERINEURAL | 648 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPRAY, METERED / NASAL | 13 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | ELIXIR / ORAL | 5.02 mg/5ml | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM / TOPICAL | 76000 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, DELAYED RELEASE / ORAL | 0.02 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | OINTMENT / DENTAL | NA | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SOLUTION/ DROPS / AURICULAR (OTIC) | 1 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SUSPENSION, EXTENDED RELEASE / ORAL | 0.12 mg/5ml | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SYRUP / ORAL | 268 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SUSPENSION / SOFT TISSUE | 26 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | TABLET, COATED / ORAL | 54.7 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRADERMAL | 1.6 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | EMULSION / INTRAVENOUS | 2.2 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | POWDER, FOR SUSPENSION / ENDOTRACHEAL | 46.76 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | TABLET / ORAL | 56 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION, SOLUTION / SUBCUTANEOUS | 4.7 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | DROPS / NASAL | NA | ||
| SORBITOL | SORBITOL | 506T60A25R | CREAM, AUGMENTED / TOPICAL | 15 %w/w | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SYSTEM / TOPICAL | 2 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | CREAM / TOPICAL | 0.4 %w/w | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | POWDER, FOR SOLUTION / ORAL | 123 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | GUM, CHEWING / BUCCAL | 5110 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / OPHTHALMIC | 2.5 %w/v | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | POWDER, FOR SOLUTION / ORAL | 199 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | LIQUID / INTRAVENOUS | 18 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SUSPENSION, EXTENDED RELEASE / ORAL | 24 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | LIQUID / ORAL | 3 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | DOUCHE / VAGINAL | 1 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SWAB / TOPICAL | 34.6 %w/w | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | TABLET, ORALLY DISINTEGRATING / ORAL | 10 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | TABLET, DELAYED RELEASE / ORAL | 0.34 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | TABLET / RECTAL | 0.6 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | PASTE / ORAL | 3 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET / ORAL | 45 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | AEROSOL, FOAM / TOPICAL | 0.27 %w/w |
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 |
|---|---|---|---|---|---|---|
| fa646d9c-3e97-40fa-9d5a-1e297ac055b4 | 50b08d7f-983c-4e87-8f7f-7bc4c99ab703 | 2024-05-23 | Warnings | 50b08d7f-983c-4e87-8f7f-7bc4c99ab703 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.