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NDC 36800-0594-40 topcare nite time cold and flu 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL Details
topcare nite time cold and flu 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL
topcare nite time cold and flu is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates LLC. The primary component is ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.
Related Packages: 36800-0594-40Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.
Related Packages: 36800-0594-40Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan
Doxylamine is used in the short-term treatment of insomnia (difficulty falling asleep or staying asleep). Doxylamine is also used in combination with decongestants and other medications to relieve sneezing, runny nose, and nasal congestion caused by the common cold. Doxylamine should not be used to cause sleepiness in children. Doxylamine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
Related Packages: 36800-0594-40Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Doxylamine
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.
Related Packages: 36800-0594-40Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 36800-0594 |
|---|---|
| Product ID | 36800-594_0827eb15-2d01-43cc-a390-ff625eb71f33 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | topcare nite time cold and flu |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 650; 20; 12.5; 10 |
| Active Ingredient Units | mg/30mL; mg/30mL; mg/30mL; mg/30mL |
| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | Topco Associates LLC |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 36800-0594-40 (36800059440)
| NDC Package Code | 36800-594-40 |
|---|---|
| Billing NDC | 36800059440 |
| Package | 355 mL in 1 BOTTLE (36800-594-40) |
| Marketing Start Date | 2019-08-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 679017b8-9d79-4a40-8953-1bdf3b5fd57e Details
Active ingredients (in each 30 mL)
Uses
temporarily relieves common cold/flu symptoms:
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- nasal congestion
- •
- sinus congestion and pressure
- •
- headache
- •
- fever
- •
- minor aches and pains
- •
- sore throat
- •
- runny nose and sneezing
- •
- cough due to minor throat and bronchial irritation
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- cough to help you sleep
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- reduces swelling of nasal passages
- •
- promotes nasal and/or sinus drainage
- •
- temporarily restores freer breathing through the nose
Warnings
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.
- •
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
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- liver disease
- •
- heart disease
- •
- high blood pressure
- •
- thyroid disease
- •
- diabetes
- •
- glaucoma
- •
- cough that occurs with too much phlegm (mucus)
- •
- a breathing problem such as emphysema or chronic bronchitis
- •
- trouble urinating due to an enlarged prostate gland
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- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
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- a sodium-restricted diet
Ask a doctor or pharmacist before use if you are
- •
- taking sedatives or tranquilizers
- •
- taking the blood thinning drug warfarin
When using this product
- •
- do not use more than directed
- •
- 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
- •
- you get nervous, dizzy or sleepless
- •
- pain, nasal congestion, or cough 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
- •
- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
Directions
Inactive ingredients
Package/Label Principal Display Panel
TopCare® health
COMPARE TO VICKS® NYQUIL® SEVERE +
VAPOCOOL™ ACTIVE INGREDIENTS
VAPOR ICE®
Nite Time Cold & Flu
SEVERE
PAIN RELIEVER-FEVER REDUCER - ACETAMINOPHEN
NASAL DECONGESTANT - PHENYLEPHRINE HCl
ANTIHISTAMINE - DOXYLAMINE SUCCINATE
COUGH SUPPRESSANT - DEXTROMETHORPHAN HBr
• Minor Aches & Pains, Fever
• Nasal Congestion & Sinus Pressure
• Sneezing, Runny Nose
• Cough
ALCOHOL 10%
12 FL OZ (355 mL)
Maximum Strength
INGREDIENTS AND APPEARANCE
| TOPCARE NITE TIME COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride solution |
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| Labeler - Topco Associates LLC (006935977) |