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NDC 36800-0859-26 topcare childrens night time cold and cough 6.25; 2.5 mg/5mL; mg/5mL Details
topcare childrens night time cold and cough 6.25; 2.5 mg/5mL; mg/5mL
topcare childrens night time cold and cough is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates LLC. The primary component is DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is also used to relieve cough caused by minor throat or airway irritation. Diphenhydramine is also used to prevent and treat motion sickness, and to treat insomnia (difficulty falling asleep or staying asleep). Diphenhydramine is also used to control abnormal movements in people who have early stage parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) or who are experiencing movement problems as a side effect of a medication. Diphenhydramine will relieve the symptoms of these conditions but will not treat the cause of the symptoms or speed recovery. Diphenhydramine should not be used to cause sleepiness in children. Diphenhydramine 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: 36800-0859-26Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Diphenhydramine
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: 36800-0859-26Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 36800-0859 |
|---|---|
| Product ID | 36800-859_b35ae8cc-a5f5-4b2a-9102-816357051d56 |
| Associated GPIs | 43993002951220 |
| 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 childrens night time cold and cough |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Diphenhydramine hydrochloride, Phenylephrine hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 6.25; 2.5 |
| Active Ingredient Units | mg/5mL; mg/5mL |
| Substance Name | DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | Topco Associates LLC |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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 36800-0859-26 (36800085926)
| NDC Package Code | 36800-859-26 |
|---|---|
| Billing NDC | 36800085926 |
| Package | 1 BOTTLE in 1 CARTON (36800-859-26) / 118 mL in 1 BOTTLE |
| Marketing Start Date | 2019-04-16 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 284d37fd-9604-4874-b99b-a119a4ba8c0f Details
Uses
Warnings
Do not use
- •
- in a child under 4 years of age
- •
- 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.
- •
- with any other product containing diphenhydramine, even one used on skin
- •
- to make a child sleepy
Ask a doctor before use if the child has
- •
- heart disease
- •
- high blood pressure
- •
- thyroid disease
- •
- diabetes
- •
- glaucoma
- •
- cough that occurs with too much phlegm (mucus)
- •
- chronic cough that lasts or as occurs with asthma
- •
- a breathing problem such as chronic bronchitis
When using this product
- •
- do not exceed recommended dosage
- •
- may cause marked drowsiness
- •
- sedatives and tranquilizers may increase drowsiness
- •
- excitability may occur, especially in children
Directions
- •
- may be given every 4 hours. Do not give more than 6 doses in 24 hours unless directed by a doctor.
- •
- use enclosed dosing cup only. Keep for use with this product only. 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 |
Inactive ingredients
Package/Label Principal Display Panel
COMPARE TO CHILDREN’S TRIAMINIC® NIGHT TIME COLD & COUGH ACTIVE INGREDIENTS
TRIACTING SYRUP
children’s Night Time Cold & Cough
ANTIHISTAMINE – COUGH SUPPRESSANT
DIPHENHYDRAMINE HCl
NASAL DECONGESTANT – PHENYLEPHRINE HCl
Cough Relief
Runny & Stuffy Nose
Itchy Throat
OUR PHARMACISTS RECOMMEND
Ages 6 to under 12 Years
GRAPE FLAVOR
4 FL OZ (118 mL)
INGREDIENTS AND APPEARANCE
| TOPCARE CHILDRENS NIGHT TIME COLD AND COUGH
diphenhydramine hydrochloride, phenylephrine hydrochloride solution |
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| Labeler - Topco Associates LLC (006935977) |