Search by Drug Name or NDC
NDC 54859-0811-16 Allergy Relief 12.5 mg/5mL Details
Allergy Relief 12.5 mg/5mL
Allergy Relief is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION. 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: 54859-0811-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Diphenhydramine
Product Information
| NDC | 54859-0811 |
|---|---|
| Product ID | 54859-811_1e39ad91-f2ba-401c-83f1-543deb7ca715 |
| 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 | Allergy Relief |
| 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 | LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION |
| 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 54859-0811-16 (54859081116)
| NDC Package Code | 54859-811-16 |
|---|---|
| Billing NDC | 54859081116 |
| Package | 473 mL in 1 BOTTLE (54859-811-16) |
| Marketing Start Date | 2019-10-01 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.0167 |
| Pricing Unit | ML |
| Effective Date | 2024-02-21 |
| NDC Description | ALLERGY RELIEF 12.5 MG/5 ML |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 1, 5 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
Standard Product Labeling (SPL)/Prescribing Information SPL e086a6d2-f664-454e-9524-f656bfbf45df Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Warnings
Do not use
- with any other product conatining diphenhydramine, including one used on the skin
- to make a child sleepy
Ask a doctor before use if you have
- a breathing problem such as chronic bronchitis or emphysema
- trouble urinating due to enlarged prostate gland
- glaucoma
Ask a doctor or pharmacist before use if you are
taking sedatives or tranquilizers.
When using this product
- excitability may occur, especially in children
- marked drowsiness may occur
- be careful when driving motor vehicle or operating machinery
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| ALLERGY RELIEF
diphenhydramine hcl liquid |
||||||||||||||||||||||
|
||||||||||||||||||||||
|
||||||||||||||||||||||
|
||||||||||||||||||||||
|
||||||||||||||||||||||
|
||||||||||||||||||||||
| Labeler - LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION (037342305) |
| Registrant - LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION (037342305) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION | 037342305 | manufacture(54859-811) | |