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NDC 54838-0135-70 Siladryl Allergy Medicine 12.5 mg/5mL Details
Siladryl Allergy Medicine 12.5 mg/5mL
Siladryl Allergy Medicine is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Lannett Company, 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: 54838-0135-70Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Diphenhydramine
Product Information
NDC | 54838-0135 |
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Product ID | 54838-135_cb6d2fa4-3d1a-4c5d-96f7-bf562c7c833b |
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 | Siladryl Allergy Medicine |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | diphenhydramine hydrochloride |
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 | Lannett Company, 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 54838-0135-70 (54838013570)
NDC Package Code | 54838-135-70 |
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Billing NDC | 54838013570 |
Package | 237 mL in 1 BOTTLE (54838-135-70) |
Marketing Start Date | 1997-01-01 |
NDC Exclude Flag | N |
Pricing Information | |
Price Per Unit | 0.01612 |
Pricing Unit | ML |
Effective Date | 2022-10-19 |
NDC Description | SILADRYL 12.5 MG/5 ML LIQUID |
Pharmacy Type Indicator | C/I |
OTC | Y |
Explanation Code | 4, 5 |
Classification for Rate Setting | G |
As of Date | 2022-11-23 |
Standard Product Labeling (SPL)/Prescribing Information SPL 1cee4078-fe92-4af2-a2dd-bde4e9ccdfbd Details
SPL UNCLASSIFIED SECTION
Uses
Warnings
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Directions
- repeat dose every 4 to 6 hours
- do not take more than 6 doses in any 24-hour period
- Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
adults and children 12 years and over | 2 to 4 teaspoonfuls (TSP) |
children 6 to under 12 years | 1 to 2 teaspoonfuls (TSP) |
children under 6 years | DO NOT USE |
Other information
Each 5 mL (1 TSP) contains: Sodium 14 mg. Store at room temperature 20°-25°C (68°-77°F).
Inactive ingredients
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
SILADRYL ALLERGY MEDICINE
diphenhydramine hydrochloride liquid |
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Labeler - Lannett Company, Inc. (002277481) |