Indications and uses
temporarily relieves common cold and flu symptoms: sore throat nasal congestion minor aches and pains fever cough due to minor throat and bronchial irritation headache
Cold and Flu
- Manufacturer
- Harmon Store Inc. | LNK International, Inc.
- Effective date
- 2021-09-24
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:34:11
Label at a glance#
ProductCold and Flu Daytime/Nightime
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE
Label structure17 sections
Dosage and administration
do not take more than directed mL = milliliter; FL OZ = fluid ounce use only enclosed dosing cup designed for use with this product. Do not use any other dosing device. do not take more than 5 doses per 24 hours adults and children 12 years and over 30 mL every 4 hours children 6 to under 12 years 15 mL every 4 hours children under 6 years do not use
Storage and handling
each 15 mL contains: sodium 13 mg store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) use by expiration date on package
Contacts and useful links#
Websitewww.facevalues.com
www.facevalues.com
www.facevalues.comLabel 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:
- sore throat
- nasal congestion
- minor aches and pains
- fever
- cough due to minor throat and bronchial irritation
- headache
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
- adult takes more than 4,000 mg of acetaminophen in 24 hours
- taken with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks every day while using this product
- child takes more than 5 doses in 24 hours
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
- if you have ever had an allergic reaction to this product or any of its ingredients
- 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 the user has
- difficulty in urination due to enlargement of the prostate gland
- cough that occurs with too much phlegm (mucus)
- liver disease
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- heart disease
- diabetes
- thyroid disease
- high blood pressure
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
- fever gets worse or lasts more than 3 days
- nervousness, dizziness, or sleeplessness occur
- new symptoms occur
- pain, nasal congestion, or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
- 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.
In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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
- mL = milliliter; FL OZ = fluid ounce
- use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
- do not take more than 5 doses per 24 hours
| adults and children 12 years and over | 30 mL every 4 hours |
| children 6 to under 12 years | 15 mL every 4 hours |
| children under 6 years | do not use |
Other information
- each 15 mL contains: sodium 13 mg
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- use by expiration date on package
Inactive ingredients
anhydrous citric acid, FD&C yellow #6, flavors, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, sodium saccharin, sorbitol, sucralose
Questions or comments?
1-800-426-9391
Active Ingredients (in each 30 mL)
Acetaminophen 650 mg
Dextromethorphan HBr 30 mg
Doxylamine succinate 12.5 mg
Purpose
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Uses
- temporarily relieves common cold and flu symptoms:
- runny nose and sneezing
- minor aches and pains
- headache
- cough due to minor throat and bronchial irritation
- fever
- sore throat
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
- if you have ever had an allergic reaction to this product or any of its ingredients
- 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
- difficulty in urination due to enlargement of the prostate gland
- cough that occurs with too much phlegm (mucus)
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
- glaucoma
- liver disease
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When using this product
- do not exceed recommended dosage
- excitability may occur, especially in children
- avoid alcoholic beverages
- marked drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
- use caution when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
- pain or cough gets worse or lasts more than 7 days
- 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.
In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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
- mL = milliliter; FL OZ = fluid ounce
- use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
- do not take more than 4 doses per 24 hours
- adults and children 12 years and over: 30 mL every 6 hours
- children under 12 years: do not use
Other information
- each 30 mL contains: sodium 18 mg
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- use by expiration date on package
Inactive ingredients
anhydrous citric acid, D&C yellow #10, FD&C green #3, FD&C yellow #6, flavors, glycerin, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sodium saccharin, sucralose
Questions or comments?
1-800-426-9391
Principal display panel
CORE VALUES™
Compare to the active ingredients in Vicks® DayQuil® Cold & Flu Multi-Symptom Relief & Vicks® NyQuil® Cold & Flu Nighttime Relief†
Daytime
Cold & Flu
Acetaminophen
Pain Reliever/Fever Reducer
Dextromethorphan HBr
Cough Suppressant
Phenylephrine HCl
Nasal Decongestant
Non-Drowsy
Alcohol-Free
menthol flavor
Nighttime
Cold & Flu
Acetaminophen
Pain Reliever/Fever Reducer
Dextromethorphan HBr
Cough Suppressant
Doxylamine succinate
Antihistamine
Alcohol-Free
eucalyptus Mint flavor
TWO - 12 FL OZ (355 mL) BOTTLES / TOTAL 24 FL OZ (710 mL)
TAMPER EVIDENT: DO NOT USE IF PRINTED NECK WRAP IS BROKEN OR MISSING
50844 REV0318A01201402
Distributed by: Liberty Procurement Co. Inc.
650 Liberty Ave., Union, NJ 07083 U.S.A.
Satisfaction Guaranteed Or Your Money Back
Visit us at www.facevalues.com
†These products are not manufactured or distributed by Procter & Gamble, owner of the registered trademark
VICKS® DayQuil® Cold & Flu Multi-Symptom Relief & VICKS® NyQuil® Cold & Flu Nighttime Relief.
Products#
Every source-derived product name is available through these pages.
- Cold and Flu Daytime/Nightime
- Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Doxylamine Succinate
- Cold and Flu Daytime
- Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- ANHYDROUS CITRIC ACID
- FD&C YELLOW NO. 6
- GLYCERIN
- POLYETHYLENE GLYCOL, UNSPECIFIED
- PROPYLENE GLYCOL
- WATER
- SODIUM BENZOATE
- TRISODIUM CITRATE DIHYDRATE
- SODIUM METABISULFITE
- SACCHARIN SODIUM
- SORBITOL
- SUCRALOSE
- Cold and Flu Nighttime
- Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate
- DOXYLAMINE SUCCINATE
- DOXYLAMINE
- D&C YELLOW NO. 10
- FD&C GREEN NO. 3
- HIGH FRUCTOSE CORN SYRUP
- SODIUM CHLORIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 63940-123 | 63940-123-08 |
| 63940-913 | 63940-913-02 |
| 63940-916 | 63940-916-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| 40781642-98b5-4a8e-a970-3b22a9016d99 | ab61098f-646d-43f5-86f5-ea4c42955a2f | 2022-06-06 | Warnings | ab61098f-646d-43f5-86f5-ea4c42955a2f |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.