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NDC 00121-0865-00 Diphenhydramine HCl Oral Solution 12.5 mg/5mL Details

Diphenhydramine HCl Oral Solution 12.5 mg/5mL

Diphenhydramine HCl Oral Solution is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Pharmaceutical Associates, 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: 00121-0865-00
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Diphenhydramine

Product Information

NDC	00121-0865
Product ID	0121-0865_c4e71fc9-c7e0-e4cd-e053-2995a90a4508
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	Diphenhydramine HCl Oral Solution
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	Pharmaceutical Associates, 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	2024-12-31

Package

Package Images

NDC 00121-0865-00 (00121086500)

Pricing Information	N/A
NDC Package Code	0121-0865-00
Billing NDC	00121086500
Package	10 TRAY in 1 CASE (0121-0865-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0865-05)
Marketing Start Date	2020-06-18
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 3c3e0dc8-cddd-4f46-9b68-19bac00c07cc Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL)

Diphenhydramine HCl 12.5 mg

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

Ask a doctor before use if the child has

a breathing problem such as chronic bronchitis
glaucoma

Ask a doctor or pharmacist before use if the child is

taking sedatives or tranquilizers

When using this product

marked drowsiness may occur
sedatives and tranquilizers may increase drowsiness
excitability may occur, especially in children

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

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

each 5 mL contains: sodium 10 mg
store between 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used.

Inactive ingredients

citric acid anhydrous, glycerin, flavoring, purified water, saccharin sodium, sodium benzoate, sodium carboxymethylcellulose, sodium citrate, sorbitol.

Questions or comments?

Call 1-800-845-8210

PRINCIPAL DISPLAY PANEL

Delivers 5 mL

NDC 0121-0865-05

Diphenydramine HCl Oral Solution USP

12.5 mg/5 mL

Antihistamine/Allergy

Alcohol Free/Dye Free/Sugar Free

Package Not Child-Resistant

PRINCIPAL DISPLAY PANEL

Delivers 10 mL

NDC 0121-1730-10

Diphenydramine HCl Oral Solution USP

25 mg/10 mL

Antihistamine/Allergy

Alcohol Free/Dye Free/Sugar Free

Package Not Child-Resistant

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HCL ORAL SOLUTION

diphenhydramine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0121-0865
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)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	white (CLEAR)	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0121-0865-00	10 in 1 CASE	06/18/2020
1		10 in 1 TRAY
1	NDC:0121-0865-05	5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2	NDC:0121-0865-30	3 in 1 CASE	06/18/2020
2		10 in 1 TRAY
2	NDC:0121-0865-05	5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	06/18/2020

DIPHENHYDRAMINE HCL ORAL SOLUTION

diphenhydramine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0121-1730
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg in 10 mL

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	white (CLEAR)	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0121-1730-00	10 in 1 CASE	06/18/2020
1		10 in 1 TRAY
1	NDC:0121-1730-10	10 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2	NDC:0121-1730-30	3 in 1 CASE	06/18/2020
2		10 in 1 TRAY
2	NDC:0121-1730-10	10 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	06/18/2020

Labeler - Pharmaceutical Associates, Inc. (044940096)

Name	Address	ID/FEI	Business Operations
Establishment
Pharmaceutical Associates, Inc.		097630693	manufacture(0121-0865, 0121-1730)

Revised: 6/2021

Document Id: c4e71fc9-c7e0-e4cd-e053-2995a90a4508

Set id: 3c3e0dc8-cddd-4f46-9b68-19bac00c07cc

Version: 2

Effective Time: 20210616

Search by Drug Name or NDC

NDC 00121-0865-00 Diphenhydramine HCl Oral Solution 12.5 mg/5mL Details

Diphenhydramine HCl Oral Solution 12.5 mg/5mL

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 00121-0865-00 (00121086500)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 3c3e0dc8-cddd-4f46-9b68-19bac00c07cc Details

SPL UNCLASSIFIED SECTION

Active ingredient (in each 5 mL)

Purpose

Uses

Warnings

Do not use

Ask a doctor before use if the child has

When using this product

Directions

Other information

Inactive ingredients

Questions or comments?

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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