Indications and uses
temporarily relieves common cold and flu symptoms: minor aches and pains headache fever sore throat nasal congestion cough due to minor throat and bronchial irritation
Cold and Flu Relief
- Manufacturer
- Gobrands, Inc. (Goodnow)
- Effective date
- 2024-06-10
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 8
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:00:55
Label at a glance#
ProductCold and Flu 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 24-hours period measure only with dosing cup provided. Do not use any other dosing device. mL = milliliter keep dosing cup with product adults and children12 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 u...
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredients (in each 15 mL)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine 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
- fever
- sore throat
- nasal congestion
- cough due to minor throat and bronchial irritation
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- adult take 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
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blistere
- 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 is 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
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- a sodium-restricted diet
- trouble urinating due to an enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough as occurs with smoking, asthma, or emphysema
Ask a doctor or pharmacist before use if 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 occur
- pain, nasal congestion, or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
- new symptoms occur
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- 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 serious 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 and 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 period
- measure only with dosing cup provided. Do not use any other dosing device.
- mL = milliliter
- keep dosing cup with product
| adults and children12 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 other Daytime or Nighttime products, carefully read each label to ensure correct dosing
Other information
- each 15 mL contains: sodium 12 mg
- store between 20º-25ºC (68º-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†
NON-DROWSY
Cold & Flu
Day Relief
Acetaminophen
Dextromethorphan HBr
Phenylephrine HCl
Pain Reliever
Fever Reducer
Cough Suppressant
Nasal Decongestant
Alcohol-free / Anthihistamine-free
Multi-Symptom Relief
Headache & Fever
Sore Throat
Minor Aches & Pains
Nasal Congestion
Cough
FL OZ (mL)
†This product is not manufactured or distributed by The Procter & Gamble Company. Vicks® and DayQuil® are registered trademarks of The Procter & Gamble Company.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.
DISTRIBUTED BY: GOBRANDS, INC.
PHILADELPHIA, PA 19123
Product Label
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 82501-4661 | COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [GOBRANDS, INC. (GOODNOW)] | 8 | Legacy NDC | 20240612_d44c2a3d-aca5-48e7-ba31-c240c931d52b.zip |
Products#
Every source-derived product name is available through these pages.
- Cold and Flu Relief
- Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- FD&C YELLOW NO. 6
- GLYCERIN
- PROPYLENE GLYCOL
- WATER
- SORBITOL
- SACCHARIN SODIUM
- SODIUM BENZOATE
- SODIUM CHLORIDE
- SODIUM CITRATE
- XANTHAN GUM
- SUCRALOSE
- ANHYDROUS CITRIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 82501-4661 | 82501-4661-2 |
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 |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITOL | 506T60A25R | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SODIUM CHLORIDE | 451W47IQ8X | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
Source Document#
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 |
|---|---|---|---|---|---|---|
| e8db42f0-814d-4c45-90a2-e037f0e57c95 | d44c2a3d-aca5-48e7-ba31-c240c931d52b | 2026-04-06 | Warnings | d44c2a3d-aca5-48e7-ba31-c240c931d52b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.