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NDC 36800-0096-91 topcare flu and severe cold and cough 650; 20; 10 mg/1; mg/1; mg/1 Details
topcare flu and severe cold and cough 650; 20; 10 mg/1; mg/1; mg/1
topcare flu and severe cold and cough is a ORAL POWDER, FOR SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates LLC. The primary component is ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; 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: 36800-0096-91Last 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: 36800-0096-91Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan
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: 36800-0096-91Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 36800-0096 |
|---|---|
| Product ID | 36800-096_cdbca6a3-90ae-4432-aabf-afee73326388 |
| Associated GPIs | 43996903403030 |
| GCN Sequence Number | 064452 |
| GCN Sequence Number Description | d-methorphan/PE/acetaminophen POWD PACK 20-10-650 ORAL |
| HIC3 | B4M |
| HIC3 Description | NON-OPIOID ANTITUSSIVE-DECONGESTANT-ANALGESIC COMB |
| GCN | 14355 |
| HICL Sequence Number | 008885 |
| HICL Sequence Number Description | DEXTROMETHORPHAN HBR/PHENYLEPHRINE HCL/ACETAMINOPHEN |
| Brand/Generic | Generic |
| Proprietary Name | topcare flu and severe cold and cough |
| Proprietary Name Suffix | daytime |
| Non-Proprietary Name | Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | POWDER, FOR SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 650; 20; 10 |
| Active Ingredient Units | mg/1; mg/1; mg/1 |
| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | Topco Associates LLC |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 36800-0096-91 (36800009691)
| NDC Package Code | 36800-096-91 |
|---|---|
| Billing NDC | 36800009691 |
| Package | 6 POWDER, FOR SOLUTION in 1 CARTON (36800-096-91) |
| Marketing Start Date | 2012-01-17 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 7c53845c-b1ea-43dc-b6d2-0b4456aa0ea1 Details
Active ingredients (in each packet)
Uses
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
- •
- in a child under 12 years of age
- •
- if you have ever had an allergic reaction to this product or any of its ingredients
- •
- 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.
Ask a doctor before use if you have
- •
- liver disease
- •
- heart disease
- •
- high blood pressure
- •
- thyroid disease
- •
- diabetes
- •
- trouble urinating due to an enlarged prostate gland
- •
- cough that occurs with too much phlegm (mucus)
- •
- cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema
- •
- a sodium-restricted diet
Stop use and ask a doctor if
- •
- nervousness, dizziness, or sleeplessness occurs
- •
- fever gets worse or lasts more than 3 days
- •
- redness or swelling is present
- •
- new symptoms occur
- •
- pain, cough or nasal congestion gets worse or lasts more than 7 days
- •
- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
Directions
- •
- do not use more than directed (see overdose warning)
- •
- take every 4 hours, while symptoms persist. Do not take more than 5 packets in 24 hours unless directed by a doctor.
|
Age |
Dose |
|
adults and children 12 years of age and over |
one packet |
|
children under 12 years of age |
do not use |
- •
- dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10-15 minutes.
- •
- if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat.
Other information
Inactive ingredients
Package/Label Principal Display Panel
TopCare® health
DAYTIME
COMPARE TO THERAFLU® DAYTIME SEVERE COLD & COUGH ACTIVE INGREDIENTS
Flu & Severe Cold & Cough
PAIN RELIEVER – FEVER REDUCER (ACETAMINOPHEN)
COUGH SUPPRESSANT (DEXTROMETHORPHAN HBr)
NASAL DECONGESTANT (PHENYLEPHRINE HCl)
NON-DROWSY
FOR SOOTHING RELIEF OF:
• Nasal & Sinus Congestion
• Sore Throat Pain
• Headache
• Body Ache
• Fever
• Cough
6 PACKETS
BERRY INFUSED WITH MENTHOL FLAVOR
INGREDIENTS AND APPEARANCE
| TOPCARE FLU AND SEVERE COLD AND COUGH
DAYTIME
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride powder, for solution |
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| Labeler - Topco Associates LLC (006935977) |