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NDC 69676-0039-09 Kids Allergy 12.5 mg/5mL Details
Kids Allergy 12.5 mg/5mL
Kids Allergy is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Genexa Inc.. 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: 69676-0039-09Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Diphenhydramine
Product Information
| NDC | 69676-0039 |
|---|---|
| Product ID | 69676-0039_de24850e-4781-f63b-e053-2a95a90a9f05 |
| 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 | Kids Allergy |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Diphenhydramine HCl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | ORAL |
| Active Ingredient Strength | 12.5 |
| Active Ingredient Units | mg/5mL |
| Substance Name | DIPHENHYDRAMINE HYDROCHLORIDE |
| Labeler Name | Genexa Inc. |
| 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 | n/a |
Package
Package Images
NDC 69676-0039-09 (69676003909)
| NDC Package Code | 69676-0039-9 |
|---|---|
| Billing NDC | 69676003909 |
| Package | 1 BOTTLE, PLASTIC in 1 CARTON (69676-0039-9) / 118 mL in 1 BOTTLE, PLASTIC |
| Marketing Start Date | 2020-07-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL a7bc5f7c-eaeb-25d0-e053-2a95a90a9ec4 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Warnings
Do not use
- to make a child sleepy
- with any other product containing diphenhydramine, even one used on skin
Ask a doctor before use if you have
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to enlargement of the prostate gland
SPL UNCLASSIFIED SECTION
Directions
- take every 4 to 6 hours, or as directed by a doctor
- do not take more than 6 doses in 24 hours
- use only with enclosed dose cup. Do not use with any other dosing device.
| adults and children 12 years of age and over | 10 20 mL |
| children 6 to under 12 years | 5 - 10 mL |
| children 2 to under 6 years | do not use unless directed by a doctor |
| children under 2 years | do not use |
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
| KIDS ALLERGY
diphenhydramine hcl liquid |
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| Labeler - Genexa Inc. (079751024) |