Indications and uses
temporarily relieves these common cold and flu symptoms: ▪ nasal congestion ▪ minor aches and pains ▪ runny nose ▪ sneezing ▪ watery eyes ▪ sore throat ▪ headache ▪ temporarily reduces fever
TopCare Nighttime Cold and Flu Simple Relief
- Manufacturer
- TOPCO ASSOCIATES LLC
- Effective date
- 2018-06-28
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:54:09
Label at a glance#
ProductTopCare Nighttime Cold and Flu Simple Relief
Active ingredientCHOLINE SALICYLATE, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections
Dosage and administration
do not exceed recommended dosage. do not take more than 6 doses in any 24-hour period. use enclosed dose cup keep dosage cup with product mL = milliliters adults and children 12 years of age and over: 30mL every 4 hours children under 12 years of age: do not use
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
TopCare Nighttime Cold & Flu Simple Relief
(choline salicylate, diphenhydramine hcI, phenylephrine hcl), solution
Topco Associates LLC
--
Topco Associates LLC. Nighttime Cold & Flu Simple Relief
Drug Facts
Active ingredients (in each 30 mL)
Choline Salicylate (NSAID)* 870 mg
Diphenhydramine HCI 50mg
Phenylephrine HCl 10 mg
Purpose
Pain reliever/fever reducer
Antihistamine
Nasal decongestant
nonsteroidal anti-inflammatory drug*
Uses
temporarily relieves these common cold and flu symptoms:
▪ nasal congestion
▪ minor aches and pains
▪ runny nose
▪ sneezing
▪ watery eyes
▪ sore throat
▪ headache
▪ temporarily reduces fever
Warnings
Reye's syndrome
Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.
Allergy alert
Salicylates (NSAIDs) may cause a severe allergic reaction which may include:
▪ hives
▪ rash
▪ shock
▪ skin reddening
▪ facial swelling ▪ asthma (wheezing)
Stomach bleeding warnings
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
▪ are age 60 or older
▪ have had stomach ulcers or bleeding problems
▪ take a blood thinning (anticoagulant) or steroid drug
▪ take other drugs containing prescription or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
▪ have 3 or more alcoholic drinks every day while using this product
▪ take more or for a longer time than directed
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 salicylates (including aspirin) or any other pain reliever / fever reducer.
▪ with any other drug containing diphenhydramine, even one used on the skin
▪ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or 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.
▪ in children under 12 years of age
Ask a doctor before use if
▪ stomach bleeding warning applies to you
▪ you have a history of stomach problems, such as heartburn or if you have ulcers or bleeding problems
▪ you have high blood pressure, heart disease, liver cirrhosis, kidney disease, diabetes, thyroid disease, or glaucoma
▪ you have a cough with excessive phlegm (mucus)
▪ you have difficulty in urination due to enlargement of the prostate gland
▪ you have breathing problems such as emphysema or chronic bronchitis
▪ you have a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Ask a doctor or pharmacist before use if you are
▪ taking a prescription drug for anticoagulation (thinning the blood), diabetes, gout, or arthritis.
▪ taking a diuretic
▪ under a doctor’s care for any serious condition
▪ taking sedatives or tranquilizers
When using this product
▪ do not use more than directed
▪ excitability may occur, especially in children
▪ marked drowsiness may occur
▪ alcohol, sedatives, and tranquilizers may increase drowsiness
▪ avoid alcoholic drinks
▪ be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
▪ an allergic reaction occurs. Seek medical help right away.
▪ pain, cough, or nasal congestion 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
▪ ringing in the ears or a loss of hearing occurs
▪ cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
▪ nervousness, dizziness, or sleeplessness occurs
▪ you experience any of the following signs of stomach bleeding:
▪ feel faint
▪ vomit blood
▪ have bloody or black stools
▪ have stomach pain that does not get better
If pregnant or breast-feeding,
ask a health professional before use. It is especially important not to use salicylates (NSAIDs) during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- do not exceed recommended dosage.
- do not take more than 6 doses in any 24-hour period.
- use enclosed dose cup
- keep dosage cup with product
- mL = milliliters
- adults and children 12 years of age and over: 30mL every 4 hours
- children under 12 years of age: do not use
Other information
- each 30mL contains: Sodium 16 mg
- tamper evident: Do not use if foil seal under cap is broken or missing.
- read all product information before using
- store at 68° to 86°F (20° to 30°C)
- avoid excessive heat and humidity
Inactive ingredients
citric acid anhydrous, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol
Questions or Comments?
Call 1-888-423-0139
PRINCIPAL DISPLAY PANEL
NDC 36800-888-08
Nighttime
Cold & Flu
Simple Relief
8 FL OZ (237mL)
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DIPHENHYDRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e4e263da-1c53-440f-bb80-b7a575843b5a | Product name | 1 | 20260313 |
| d2168cac-a261-415a-9c78-3522859fa720 | Product name | 3 | 20251124 |
| 05a8cdd1-eeb8-409e-b938-0778225eca7d | Product name | 4 | 20250221 |
| e5b5c132-b15d-435b-9faa-2f74e5cadcf9 | Product name | 8 | 20250220 |
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| f489e8f3-5c9e-4818-b539-a73587edcfc7 | Product name | 2 | 20240229 |
| 0f7ae452-206d-4fc4-868d-56fc47074084 | Product name | 1 | 20231011 |
| b5abe2e3-39a1-43eb-9bff-f3c1653fe3df | Product name | 2 | 20190930 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 42f3c020-f1b3-89bc-7bdc-e1f10e680485 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 36800-888-08 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-18b1-f424-e053-dadaa90a57ce | TOP CARE NIGHTTIME COLD AND FLU SIMPLE RELIEF |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 36800-888-08 | TopCare Nighttime Cold and Flu Simple Relief | 237 mL in 1 BOTTLE | LIQUID | 237 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 36800-888 | TOPCARE NIGHTTIME COLD AND FLU SIMPLE RELIEF (CHOLINE SALICYLATE, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [TOPCO ASSOCIATES LLC] | 1 | 1 package rows | 20180116_aa264ce6-41a0-4099-86c7-5fcdc1bb9da3.zip |
Products#
Every source-derived product name is available through these pages.
- TopCare Nighttime Cold and Flu Simple Relief
- Choline Salicylate, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
- CHOLINE SALICYLATE
- SALICYLIC ACID
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- ANHYDROUS CITRIC ACID
- GLYCERIN
- PROPYLENE GLYCOL
- WATER
- SODIUM BENZOATE
- SODIUM CITRATE
- SACCHARIN SODIUM
- SORBITOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 36800-888 | 36800-888-08 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CHOLINE SALICYLATE | KD510K1IQW | ACTIB |
| DIPHENHYDRAMINE HYDROCHLORIDE | TC2D6JAD40 | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SORBITOL | 506T60A25R | 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 |
|---|---|---|---|---|---|---|
| 9871f8a8-da4a-4b65-8894-31155083b466 | aa264ce6-41a0-4099-86c7-5fcdc1bb9da3 | 2018-06-28 | Warnings | 9871f8a8-da4a-4b65-8894-31155083b466 aa264ce6-41a0-4099-86c7-5fcdc1bb9da3 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.