Indications and uses
temporarily relieves cold/flu symptoms: sore throat minor aches and pain runny nose and sneezing cough due to minor sore throat and bronchial irritation headache fever
Nite-TimeCOLD/FLU CHERRY
- Manufacturer
- Salado Sales, Inc. | AptaPharma Inc.
- Effective date
- 2023-12-29
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 8
- Source
- full-release
- Hydrated at
- 2026-06-01 00:06:02
Label at a glance#
ProductNite-TimeCOLD/FLU CHERRY COLD/FLU CHERRY
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Label structure16 sections
Dosage and administration
take only as recommended-see Overdose warnings Use dose cup or tablespoon (TBSP) do not exceed 4 doses per 24 hours adults & children 12 years and over 30 mL (2 TBSP) every 6 hours children 4 to under 12 years ask a doctor children under 4 years do not use If taking Nite Time at night and Day Time during the day, limit tota...
Contacts and useful links#
Websitewww.saladosales.com
www.saladosales.com
www.saladosales.comLabel contents#
Full prescribing information#
Drug FactsActive ingredients (in each 30 mL dose cup)
Acetaminophen 650 mg
Dextromethorphan HBr 30 mg
Doxylamine Succinate 12.5 mg
Purpose
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Keep Out Of Reach Of Children
Keep out of reach of children.
Uses
temporarily relieves cold/flu symptoms:
- sore throat
- minor aches and pain
- runny nose and sneezing
- cough due to minor sore throat and bronchial irritation
- headache
- fever
Warnings
Failure to follow these warnings could result in serious consequences
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
- 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
- to make a child sleepy
Ask a doctor before use if you have
- a sodium restricted diet
- liver disease
- glaucoma
- 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
- trouble urinating due to enlarged prostate gland
Ask a doctor or pharmacist before use
- if you are taking sedatives or tranquilizers
- if you are taking the blood thinning drug warfarin
When using this product
- do not use more than directed
- avoid alcoholic drinks
- excitability may occur, especially in children
- marked drowsiness may occur
- be careful when driving a motor vehicle or operating machinery
- alcohol, sedatives, and tranquilizers may increase drowsiness
Stop use and ask a doctor if
- redness or swelling is present
- symptoms do not get better within 7 days or are accompanied by a fever
- fever gets worse or lasts more than 3 days
- new symptoms occur
- cough lasts more than 7 days, comes back, or occurs with fever, rash, headache that lasts
These could be signs of a serious condition.
Pregnant Or Breast-Feeding
ask a health professional before use.
Overdose warning
Taking more than the recommended dose 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 as well as for children even if you do not notice any signs or symptoms.
Directions
- take only as recommended-see Overdose warnings
- Use dose cup or tablespoon (TBSP)
- do not exceed 4 doses per 24 hours
adults & children 12 years and over 30 mL (2 TBSP) every 6 hours
children 4 to under 12 years ask a doctor
children under 4 years do not use
- If taking Nite Time at night and Day Time during the day, limit total to 4 doses per 24 hours
Other Information
- each 30 mL dose cup contains:
- sodium 45 mg
- store at room temperature
Inactive ingredients
citric acid, FD and C Blue No. 1, FD&C Red No. 40, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sucrose
Nite Time Cherry product label
Compare to VICKS® NYQUIL® active ingredients
CVP® CONSUMER VALUE PRODUCTS
Nite-Time COLD/FLU Medicine
Multi-Symptom CHERRY FLAVOR
Acetaminophen • Aches, Fever & Sore Throat
Dextromethorphan • Cough
Doxylamine Succinate • Sneezing, Runny nose
6 FL OZ (177 mL)
DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN
*This product is not manufactured or distributed by Proctor and Gamble, distributor of Vicks® Nyquil® LR-003
Questions? Call weekdays from 9:30am to 4:30pm EST 1-877-795-5944
LR-003 Rev 02
Distributed by:
Salado Sales, Inc.
P.O. Box 6115 Temple, TX 76503 www.saladosales.com
LOT: EXP:
Peel Here DRUG FACTS CONTINUED ON BACK
CHERRY FLAVOR Nite-Time Multi-Symptom COLD/FLU Medicine
- Antihistamine
- Cough Suppressant
- Pain Reliever
- Fever Reducer
res
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution | PSN | 8 |
| 1043400 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SCD | 8 |
| 1043400 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution | SY | 8 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution | SY | 8 |
| 1043400 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SY | 8 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| DOXYLAMINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| f4368033-af8c-41bf-a84b-ff77392b8522 | Product name | 1 | 20161229 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 57243-502-25 | Nite-TimeCOLD/FLU CHERRYCOLD/FLU CHERRY | 177 mL in 1 BOTTLE | LIQUID | 177 | 8 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 57243-502 | NITE-TIMECOLD/FLU CHERRY COLD/FLU CHERRY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.] | 8 | Current NDC, Legacy NDC, 1 package rows | 20231230_e6c3e545-b2ad-47f0-8318-c134a8e24f5b.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 6 | |
| DEXTROMETHORPHAN HYDROBROMIDE | ACTIVE INGREDIENT | 9D2RTI9KYH | 6 | |
| DOXYLAMINE SUCCINATE | ACTIVE INGREDIENT | V9BI9B5YI2 | 6 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 6 | |
| DEXTROMETHORPHAN | ACTIVE MOIETY | 7355X3ROTS | 6 | |
| DOXYLAMINE | ACTIVE MOIETY | 95QB77JKPL | 6 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | 6 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 6 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 6 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 6 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | 6 | |
| SACCHARIN SODIUM DIHYDRATE | INACTIVE INGREDIENT | SB8ZUX40TY | 6 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | 6 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | 6 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | 6 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 6 |
Products#
Every source-derived product name is available through these pages.
- Nite-TimeCOLD/FLU CHERRY COLD/FLU CHERRY
- ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- DOXYLAMINE SUCCINATE
- DOXYLAMINE
- CITRIC ACID MONOHYDRATE
- FD&C BLUE NO. 1
- FD&C RED NO. 40
- GLYCERIN
- POLYETHYLENE GLYCOL 400
- WATER
- SACCHARIN SODIUM
- SODIUM BENZOATE
- SODIUM CITRATE
- SUCROSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 57243-502 | 57243-502-25 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| DOXYLAMINE SUCCINATE | V9BI9B5YI2 | ACTIB |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| WATER | 059QF0KO0R | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| SUCROSE | C151H8M554 | 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 |
|---|---|---|---|---|---|---|
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | TABLET, EXTENDED RELEASE / ORAL | 60 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SOLUTION / ORAL | 660 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | LIQUID / ORAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LIQUID / ORAL | 2400 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, COATED / ORAL | 0.1 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | TABLET, FILM COATED / ORAL | 1 mg | ||
| SACCHARIN SODIUM DIHYDRATE | SACCHARIN SODIUM | SB8ZUX40TY | LIQUID / ORAL | 3 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CONCENTRATE / ORAL | 0.04 mg/1ml | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET / ORAL | 7 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SUSPENSION / ORAL | 320 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | CAPSULE, DELAYED RELEASE / ORAL | 26 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | GRANULE, FOR SUSPENSION / ORAL | 120 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | CONCENTRATE / ORAL | 20 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | POWDER, FOR SUSPENSION / ORAL | 3 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | TABLET, FILM COATED / ORAL | 20 mg | ||
| SACCHARIN SODIUM DIHYDRATE | SACCHARIN SODIUM | SB8ZUX40TY | LIQUID / ORAL | 3 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | LIQUID / TOPICAL | 1 %w/w | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, EXTENDED RELEASE / ORAL | 1 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | GRANULE, EFFERVESCENT / ORAL | 60 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | DROPS / ORAL | NA | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 0.02 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SOLUTION / ORAL | 38 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | TABLET, EXTENDED RELEASE / ORAL | NA | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET / ORAL | 7 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | CONCENTRATE / ORAL | 20 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, DELAYED RELEASE / ORAL | 2 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | CAPSULE / ORAL | 13440 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SUSPENSION, EXTENDED RELEASE / ORAL | 24 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, CHEWABLE / ORAL | 40 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | POWDER, FOR SOLUTION / ORAL | 0.33 mg/5ml | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | SYRUP / ORAL | 740 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | POWDER, FOR SUSPENSION / ORAL | 160 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | TABLET, ORALLY DISINTEGRATING / ORAL | 2 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, EXTENDED RELEASE / ORAL | 2.22 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | ELIXIR / ORAL | 12.5 mg/5ml | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | GRANULE / ORAL | NA | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CONCENTRATE / ORAL | 0.04 mg/1ml | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | POWDER, FOR SOLUTION / ORAL | 98 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, COATED / ORAL | NA | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SOLUTION / ORAL | 38 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | CAPSULE, LIQUID FILLED / ORAL | 1122 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | FILM, SOLUBLE / ORAL | 29 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | LIQUID / ORAL | 37500 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | LIQUID / TOPICAL | 1 %w/w | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | GRANULE / ORAL | NA | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, COATED / ORAL | NA | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | LIQUID / ORAL | 114 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | CONCENTRATE / ORAL | 3000 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | ELIXIR / ORAL | 5.02 mg/5ml | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, COATED PELLETS / ORAL | NA | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 2 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | FILM, SOLUBLE / ORAL | 29 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | SUSPENSION / ORAL | 400 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | TABLET, COATED / ORAL | 0.2 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | TABLET / ORAL | 30 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | POWDER, FOR SUSPENSION / ORAL | 160 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | SUSPENSION / ORAL | 400 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SUSPENSION / ORAL | 100 mg/5ml | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | TABLET / ORAL | 30 mg |
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 |
|---|---|---|---|---|---|---|
| Nite-TimeCOLD/FLU CHERRY COLD/FLU CHERRY | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Salado Sales, Inc. | e6c3e545-b2ad-47f0-8318-c134a8e24f5b | 2023-12-29 | Warnings | 57243-502-25 57243-502 57243050225 21dee833-1f0b-4ac7-a662-169dc2fc6d0a e6c3e545-b2ad-47f0-8318-c134a8e24f5b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.