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NDC 36800-0379-34 Topcare childrens allergy 12.5 mg/5mL Details
Topcare childrens allergy 12.5 mg/5mL
Topcare childrens allergy 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.
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: 36800-0379-34Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Diphenhydramine
Product Information
| NDC | 36800-0379 |
|---|---|
| Product ID | 36800-379_b0992995-42fa-4e5d-8753-0f9bbe179d09 |
| Associated GPIs | 41200030100920 |
| GCN Sequence Number | 016675 |
| GCN Sequence Number Description | diphenhydramine HCl LIQUID 12.5MG/5ML ORAL |
| HIC3 | Z2P |
| HIC3 Description | ANTIHISTAMINES - 1ST GENERATION |
| GCN | 48831 |
| HICL Sequence Number | 004480 |
| HICL Sequence Number Description | DIPHENHYDRAMINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | Topcare childrens allergy |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Diphenhydramine Hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 12.5 |
| Active Ingredient Units | mg/5mL |
| Substance Name | DIPHENHYDRAMINE HYDROCHLORIDE |
| Labeler Name | Topco Associates LLC |
| Pharmaceutical Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 36800-0379-34 (36800037934)
| NDC Package Code | 36800-379-34 |
|---|---|
| Billing NDC | 36800037934 |
| Package | 1 BOTTLE in 1 CARTON (36800-379-34) / 237 mL in 1 BOTTLE |
| Marketing Start Date | 2003-11-18 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 6b784cde-3152-4421-a825-dd1fc601aa7a Details
Uses
Warnings
Do not use
- •
- 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
- •
- a breathing problem such as chronic bronchitis
- •
- glaucoma
- •
- a sodium-restricted diet
Directions
- •
- find right dose on chart below
- •
- mL = milliliter
- •
- take every 4 to 6 hours, or as directed by a doctor
- •
- do not take more than 6 doses in 24 hours
|
Age (yr) |
Dose (mL) |
|
children under 2 years |
do not use |
|
children 2 to 5 years |
do not use unless directed by a doctor |
|
children 6 to 11 years |
5 mL to 10 mL |
Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
Other information
Inactive ingredients
Principal Display Panel
TopCare® health
COMPARE TO CHILDREN’S BENADRYL® ALLERGY LIQUID ACTIVE INGREDIENT
children’s Allergy Liquid
ANTIHISTAMINE
DIPHENHYDRAMINE HCl
12.5 mg/5 mL ORAL SOLUTION
4-6 HOURS/DOSE
RELIEF OF:
• Runny Nose
• Sneezing
• Itchy, Watery Eyes
• Ithy Throat or Nose
Alcohol Free
Ages 6 to 11 Years
CHERRY FLAVOR
8 FL OZ (237 mL)
INGREDIENTS AND APPEARANCE
| TOPCARE CHILDRENS ALLERGY
diphenhydramine hydrochloride solution |
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| Labeler - Topco Associates LLC (006935977) |