![TOPCARE COUGH COLD AND FLU SIMPLE RELIEF (CHOLINE SALICYLATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]](https://medic.hrt.org//dailymed/images/dbf8fc4f-5ba9-4f87-a772-b985586823b6/topcare-cough-cold-and-flu-simple-relief-01.jpg)
![TOPCARE COUGH COLD AND FLU SIMPLE RELIEF (CHOLINE SALICYLATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]](https://medic.hrt.org//dailymed/images/dbf8fc4f-5ba9-4f87-a772-b985586823b6/topcare-cough-cold-and-flu-simple-relief-02.jpg)
| NDC | 36800-777-08 |
| Set ID | dbf8fc4f-5ba9-4f87-a772-b985586823b6 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | TOPCO ASSOCIATES LLC |
| Generic Name | |
| Product Class | alpha-1 Adrenergic Agonist |
| Product Number | |
| Application Number | PART341 |
- SPL UNCLASSIFIED SECTION
- Active ingredients (in each 30 mL)
- Purpose
-
Uses
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
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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.
▪ 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 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 a chronic pulmonary disease or shortness of breath
▪ you have asthma
▪ you are taking a diuretic
Ask a doctor or pharmacist before use if you are
▪ taking a prescription drug for anticoagulation (thinning the blood), diabetes, gout, or arthritis.
▪ under a doctor’s care for any serious condition
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
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Directions
-
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 -
do not exceed recommended dosage.
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TOPCARE COUGH COLD AND FLU SIMPLE RELIEF
choline salicylate, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-777 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHOLINE SALICYLATE (UNII: KD510K1IQW) (SALICYLIC ACID - UNII:O414PZ4LPZ) CHOLINE SALICYLATE 870 mg in 30 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg in 30 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg in 30 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg in 30 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE (UNII: 1Q73Q2JULR) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBITOL (UNII: 506T60A25R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-777-08 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/06/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 09/06/2016 Labeler - TOPCO ASSOCIATES LLC (006935977)
