Indications and uses
temporarily relieves these common cold/flu symptoms: minor aches and pains headache sore throat fever runny nose and sneezing cough due to minor throat and bronchial irritation
Cold and Flu Relief
- Manufacturer
- Freds Inc
- Effective date
- 2023-11-28
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:19:58
Label at a glance#
ProductCold and Flu Relief Nighttime
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Label structure9 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 6 hours children under 12 years of age: do not use When using other Day Time or Night Time products, carefully read each label to ensure corr...
Storage and handling
each 30 mL contains: potassium 5 mg, each 30 mL contains sodium 24 mg store between 20-25ºC (68-77ºF). Do not refrigerate.
Contacts and useful links#
Websitewww.fredsinc.com
www.fredsinc.com
www.fredsinc.comLabel contents#
Full prescribing information#
Active ingredients (in each 30 mL)
Acetaminophen 650 mg
Dextromethorphan HBr 30 mg
Doxylamine succinate 12.5 mg
Purposes
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Uses
- temporarily relieves these common cold/flu symptoms:
- minor aches and pains
- headache
- sore throat
- fever
- runny nose and sneezing
- cough due to minor throat and bronchial irritation
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4 doses ( 8 tablespoons or 120 mL) in 24 hours, which is the maximum daily amount
- 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 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
- glaucoma
- cough that occurs with too much phlegm (mucus)
- breathing problems or chronic cough that lasts or occurs with smoking, asthma, chronic bronchitis or emphysema
- trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are taking
- sedatives or tranquilizers
- the blood thinning drug warfarin
When using this product
- excitability may occur, especially in children
- marked drowsiness may occur
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
- alcohol, sedatives and tranquilizers may increase drowsiness
Stop use and ask a doctor if
- pain or cough gets worse or lasts more than 7 days
- redness or swelling is present
- new symptoms occur
- fever gets worse or lasts more than 3 days
- 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 6 hours
- children under 12 years of age: do not use
- When using other Day Time or Night Time products, carefully read each label to ensure correct dosing
Other information
- each 30 mL contains: potassium 5 mg,
- each 30 mL contains sodium 24 mg
- store between 20-25ºC (68-77ºF). Do not refrigerate.
Inactive ingredients
acesulfame potassium, alcohol, citric acid, FD&C blue 1, FD&C red 40, flavor,high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate
Principal Display Panel
NIGHTTIME RELIEF
Cold & Flu
Each dose (per 30 mL) of oral solution contains:
650 mg-Acetaminophen (Pain Reliever/Fever Reducer)
30 mg- Dextromethorphan HBr (Cough Suppressant)
12.5 mg- Doxylamine succinate (Antihistamine)
- Aches, fever & Sore Throat
- Sneezing, Runny Nose
- Cough
Alcohol 10 % • Ages 12+
FL OZ (mL)
Cherry Flavor
Compare to the Active Ingredients in Vicks® Nyquil®*
*This product is not manufactured or distributed by The Procter & Gamble, Vicks® NyQuil® 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: fred's Inc,
4300 NEW GETWELL RD., MEMPHIS, TN 38118
Product Label
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55315-443-12 | 2021-10-19 | C162847 | 48780-1 | ba0f9c33-3f3c-a910-e053-dadaa90a0b85 | Drug Facts |
| 55315-443-12 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-3f3c-a910-e053-dadaa90a0b85 | Drug Facts |
Products#
Every source-derived product name is available through these pages.
- Cold and Flu Relief Nighttime
- Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- DOXYLAMINE SUCCINATE
- DOXYLAMINE
- PROPYLENE GLYCOL
- WATER
- ACESULFAME POTASSIUM
- ALCOHOL
- ANHYDROUS CITRIC ACID
- HIGH FRUCTOSE CORN SYRUP
- POLYETHYLENE GLYCOL, UNSPECIFIED
- SACCHARIN SODIUM
- TRISODIUM CITRATE DIHYDRATE
- FD&C BLUE NO. 1
- FD&C RED NO. 40
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55315-443 | 55315-443-12 |
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 |
|---|---|---|---|---|---|---|
| 206b41d8-e6e4-46b0-b5b1-2f61bb18547b | c6efd0fc-85e4-429c-a96e-4e4f7ff577ff | 2023-11-28 | Warnings | 206b41d8-e6e4-46b0-b5b1-2f61bb18547b c6efd0fc-85e4-429c-a96e-4e4f7ff577ff |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.