Search by Drug Name or NDC

NDC 71205-0410-04 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 Proficient Rx LP. 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: 71205-0410-04
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Diphenhydramine

Product Information

NDC	71205-0410
Product ID	71205-410_098b27f9-2c4b-4fd0-a4ec-d9213de4181a
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	Proficient Rx LP
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 71205-0410-04 (71205041004)

Pricing Information	N/A
NDC Package Code	71205-410-04
Billing NDC	71205041004
Package	118 mL in 1 BOTTLE (71205-410-04)
Marketing Start Date	2020-02-25
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c4a35a3e-253a-4815-964a-892d17832252 Details

SPL UNCLASSIFIED SECTION

Active Ingredient: Diphenhydramine HCl 12.5 mg (in each 5 mL (teaspoonful)(TSP))

SPL UNCLASSIFIED SECTION

Purpose: Antihistamine

Uses

•

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

•

•: runny nose
•: sneezing
•: itchy, watery eyes
•: itching of the nose or throat

Warnings

Do not use

•: to make a child sleepy
•: with any other product containing diphenhydramine, even one used on skin.

SPL UNCLASSIFIED SECTION

Ask a doctor before use if you have

•: glaucoma
•: trouble urinating due to an enlarged prostate gland
•: a breathing problem such as emphysema or chronic bronchitis
•: a sodium restricted diet

SPL UNCLASSIFIED SECTION

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

SPL UNCLASSIFIED SECTION

When using this product

•: marked drowsiness may occur
•: avoid alcoholic drinks
•: alcohol, sedatives, and tranquilizers may increase drowsiness
•: be careful when driving a motor vehicle or operating machinery
•: excitability may occur, especially in children

SPL UNCLASSIFIED SECTION

If pregnant or breast-feeding, ask a health professional before use.

SPL UNCLASSIFIED SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

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

citric acid, D&C red no. 33, FD&C red no. 40, black cherry flavor, methylparaben, propylene glycol, propylparaben, saccharin sodium, sodium citrate, sorbitol, water.

SPL UNCLASSIFIED SECTION

Questions

1-844-834-0530

Manufactured by:

Silarx Pharmaceuticals, Inc.

Carmel, NY 10512

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

10-1043 Rev. 04/18

PRINCIPAL DISPLAY PANEL

Siladryl Allergy 118 mL 10-1043 Rev. 04/18

INGREDIENTS AND APPEARANCE

SILADRYL ALLERGY MEDICINE

diphenhydramine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71205-410(NDC:54838-135)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY (black cherry)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71205-410-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/25/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	01/01/1997

Labeler - Proficient Rx LP (079196022)

Name	Address	ID/FEI	Business Operations
Establishment
Proficient Rx LP		079196022	REPACK(71205-410) , RELABEL(71205-410)

Revised: 4/2022

Document Id: 098b27f9-2c4b-4fd0-a4ec-d9213de4181a

Set id: c4a35a3e-253a-4815-964a-892d17832252

Version: 3

Effective Time: 20220401

Search by Drug Name or NDC

NDC 71205-0410-04 Siladryl Allergy Medicine 12.5 mg/5mL Details

Siladryl Allergy Medicine 12.5 mg/5mL

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 71205-0410-04 (71205041004)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL c4a35a3e-253a-4815-964a-892d17832252 Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Uses

Warnings

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Directions

Inactive ingredients

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

Concerns With Metoprolol Causing Alopecia (Hair Loss)

Can You Take A Z-Pak If You Have A Penicillin Allergy?