temporarily relieves these common cold and flu symptoms: ▪ cough ▪ nasal congestion ▪ minor aches and pains ▪ sore throat ▪ headache ▪ temporarily reduces fever ▪ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
do not exceed recommended dosage. do not take more than 6 doses in any 24-hour period. measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor mL = milliliters age dose adults and children 12 years of age and over 30 mL every 4 hours children under 12 years of age do not use
TOPCARE COUGH COLD & FLU SIMPLE RELIEF
(choline salicylate, dextromethorphan hbr, guaifenesin, phenylephrine hcl), solution
Topco Associates LLC
--
Topco Associates LLC. Cough Cold & Flu Simple Relief Drug Facts
Drug Facts
Choline Salicylate (NSAID)* 870 mg
Dextromethorphan HBr 20 mg
Guaifenesin 200 mg
Phenylephrine HCl 10 mg
Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant
*nonsteroidal anti-inflammatory drug
temporarily relieves these common cold and flu symptoms:
▪ cough
▪ nasal congestion
▪ minor aches and pains
▪ sore throat
▪ headache
▪ temporarily reduces fever
▪ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
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.
▪ if you have ever had an allergic reaction to salicylates (including aspirin) or any other pain reliever/fever reducer.
▪ 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
▪ 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 or thyroid disease
▪ you have a cough with excessive phlegm (mucus)
▪ you have difficulty in urination due to enlargement of the prostate gland
▪ you have a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
▪ you have asthma
▪ you are taking a diuretic
▪ taking a prescription drug for anticoagulation (thinning the blood), diabetes, gout, or arthritis.
▪ under a doctor’s care for any serious condition
do not use more than directed
▪ 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
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.
In case of overdose, get medical help or contact a Poison Control Center right away.
| age | dose |
| adults and children 12 years of age and over | 30 mL every 4 hours |
| children under 12 years of age | do not use |
▪ each 30mL contains: Sodium 1 6 mg
▪ store at room temperature 68°- 86°F (20°- 30°C)
citric acid, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol
Call 1-888-423-0139
NDC 36800-777-08
TopCare
health
Cough, Cold
& Flu
SIMPLE RELIEF
8 FL OZ (237mL)
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1653134 | choline salicylate 870 MG / dextromethorphan HBr 20 MG / guaiFENesin 200 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution | PSN | 1 |
| 1653134 | choline salicylate 29 MG/ML / dextromethorphan hydrobromide 0.67 MG/ML / guaifenesin 6.67 MG/ML / phenylephrine hydrochloride 0.33 MG/ML Oral Solution | SCD | 1 |
| 1653134 | choline salicylate 870 MG / dextromethorphan HBr 20 MG / guaifenesin 200 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | 1 |
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 4fe95224-f543-4dbb-9445-8cca122b48c8 | Product name | 1 | 20150609 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 106ff02a-57e1-4c4c-a307-fd582ff4e311 | Product name | 1 | 20150212 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 36800-777-08 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-9586-f424-e053-dadaa90a57ce | TOPCARE COUGH COLD AND FLU SIMPLE RELIEF |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 36800-777-08 | TOPCARE COUGH COLD AND FLU SIMPLE RELIEF | 237 mL in 1 BOTTLE | LIQUID | 237 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 36800-777 | TOPCARE COUGH COLD AND FLU SIMPLE RELIEF (CHOLINE SALICYLATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [TOPCO ASSOCIATES LLC] | 1 | Legacy NDC, 1 package rows | 20180126_dbf8fc4f-5ba9-4f87-a772-b985586823b6.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 36800-777 | 36800-777-08 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CHOLINE SALICYLATE | KD510K1IQW | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| GUAIFENESIN | 495W7451VQ | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | 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 |
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 |
|---|---|---|---|---|---|---|
| f769b02d-68b2-4816-a183-a4f1978da47a | dbf8fc4f-5ba9-4f87-a772-b985586823b6 | 2016-06-28 | Warnings | f769b02d-68b2-4816-a183-a4f1978da47a dbf8fc4f-5ba9-4f87-a772-b985586823b6 |
Adverse event summaries are temporarily unavailable. Other product information remains available.