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NDC 36800-0903-26 Topcare Cold 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL Details
Topcare Cold 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL
Topcare Cold is a ORAL SUSPENSION in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates LLC. The primary component is ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; 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: 36800-0903-26Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen
Chlorpheniramine relieves red, itchy, watery eyes; sneezing; itchy nose or throat; and runny nose caused by allergies, hay fever, and the common cold. Chlorpheniramine helps control the symptoms of cold or allergies but will not treat the cause of the symptoms or speed recovery. Chlorpheniramine 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: 36800-0903-26Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Chlorpheniramine
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: 36800-0903-26Last 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: 36800-0903-26Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 36800-0903 |
|---|---|
| Product ID | 36800-903_b8bde0b4-2987-4d9e-986e-7988933439dc |
| Associated GPIs | 43995904161820 |
| GCN Sequence Number | 061404 |
| GCN Sequence Number Description | DM/pe/acetaminophen/chlorphenr ORAL SUSP 5-2.5-160 ORAL |
| HIC3 | B3P |
| HIC3 Description | NON-OPIOID ANTITUS-1STGEN ANTIHIST-DECON-ANALGESIC |
| GCN | 97196 |
| HICL Sequence Number | 000372 |
| HICL Sequence Number Description | DEXTROMETHORPHAN/PHENYLEPHRINE/ACETAMINOPHEN/CHLORPHENIRAMIN |
| Brand/Generic | Generic |
| Proprietary Name | Topcare Cold |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SUSPENSION |
| Route | ORAL |
| Active Ingredient Strength | 160; 1; 5; 2.5 |
| Active Ingredient Units | mg/5mL; mg/5mL; mg/5mL; mg/5mL |
| Substance Name | ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | Topco Associates LLC |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Rece |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 36800-0903-26 (36800090326)
| NDC Package Code | 36800-903-26 |
|---|---|
| Billing NDC | 36800090326 |
| Package | 1 BOTTLE in 1 CARTON (36800-903-26) / 118 mL in 1 BOTTLE |
| Marketing Start Date | 2009-07-24 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 258e679c-4862-4ad8-a62f-bb5da2eaa41a Details
Active ingredients (in each 5 mL)
Uses
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- temporarily relieves
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- minor aches and pains
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- headache
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- minor sore throat pain
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- runny nose
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- itchy nose or throat
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- sneezing
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- itchy, watery eyes due to hay fever
- •
- nasal and sinus congestion
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- cough due to minor throat and bronchial irritation as may occur with a cold
- •
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes
- •
- more than 5 doses in 24 hours, which is the maximum daily amount
- •
- with other drugs containing acetaminophen
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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- 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
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- in a child under 4 years of age
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- if your child has ever had an allergic reaction to this product or any of its ingredients
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- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- •
- in a child who is 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 child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
- •
- to make a child sleepy
Ask a doctor before use if your child has
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- liver disease
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- heart disease
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- high blood pressure
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- thyroid disease
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- diabetes
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- glaucoma
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- a breathing problem such as chronic bronchitis
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- cough that occurs with too much phlegm (mucus)
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- persistent or chronic cough such as occurs with asthma
Ask a doctor or pharmacist before use if your child is taking
- •
- sedatives or tranquilizers
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- blood thinning drug warfarin
When using this product
- •
- do not exceed recommended dosage
- •
- marked drowsiness may occur
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- sedatives and tranquilizers may increase drowsiness
- •
- excitability may occur, especially in children
Stop use and ask a doctor if
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- nervousness, dizziness or sleeplessness occur
- •
- pain, nasal congestion or cough gets worse or lasts more than 5 days
- •
- fever gets worse or lasts more than 3 days
- •
- redness or swelling is present
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- new symptoms occur
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- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
Directions
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- this product does not contain directions or complete warnings for adult use
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- do not give more than directed (see Overdose warning)
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- shake well before using
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- remove the child protective cap and squeeze your child’s dose into the dosing cup
- •
- may be given every 4 hours, while symptoms persist. Do not give more than 5 doses in 24 hours unless directed by a doctor.
- •
- use enclosed dosing cup only. Keep for use with this product. Do not use any other dosing device.
|
Age |
Dose |
|
children under 4 years of age |
do not use |
|
children 4 to under 6 years of age |
do not use unless directed by a doctor |
|
children 6 to under 12 years of age |
10 mL |
Other information
Inactive ingredients
Principal Display Panel
COMPARE TO CHILDREN’S TRIAMINIC® MULTI-SYMPTOM FEVER & COLD
ACTIVE INGREDIENTS
TRIACTING SUSPENSION
children’s Pain Relief Plus Multi-Symptom Cold
OUR PHARMACISTS RECOMMEND
FEVER REDUCER - PAIN RELIEVER - ACETAMINOPHEN
COUGH SUPPRESSANT - DEXTROMETHORPHAN HBr
NASAL DECONGESTANT - PHENYLEPHRINE HCl
ANTIHISTAMINE - CHLORPHENIRAMINE MALEATE
Cold & Flu Symptom Relief
Runny & Stuffy Nose
Aches & Pains
Fever
Sore Throat
Cough
Ages 6 to under 12 Years
GRAPE FLAVOR
4 FL OZ (118 mL)
INGREDIENTS AND APPEARANCE
| TOPCARE COLD
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl suspension |
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| Labeler - Topco Associates LLC (006935977) |