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NDC 70518-1289-00 Banophen 50 mg/1 Details

Banophen 50 mg/1

Banophen is a ORAL CAPSULE in the HUMAN OTC DRUG category. It is labeled and distributed by REMEDYREPACK 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: 70518-1289-00
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Diphenhydramine

Product Information

NDC	70518-1289
Product ID	70518-1289_e8a781d1-e992-2cd4-e053-2a95a90adc4e
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	Banophen
Proprietary Name Suffix	n/a
Non-Proprietary Name	diphenhydramine hcl
Product Type	HUMAN OTC DRUG
Dosage Form	CAPSULE
Route	ORAL
Active Ingredient Strength	50
Active Ingredient Units	mg/1
Substance Name	DIPHENHYDRAMINE HYDROCHLORIDE
Labeler Name	REMEDYREPACK 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	2023-12-31

Package

Package Images

NDC 70518-1289-00 (70518128900)

Pricing Information	N/A
NDC Package Code	70518-1289-0
Billing NDC	70518128900
Package	30 CAPSULE in 1 BLISTER PACK (70518-1289-0)
Marketing Start Date	2018-08-09
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 28a98e8d-98c9-4e7c-b978-b567cb280f94 Details

Active Ingredient (in each banded capsule)

Diphenhydramine Hydrochloride 50 mg

Purpose

Antihistamine

Use

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

runny nose
sneezing
itchy, watery eyes
itchy throat and nose
Temporarily relieves these symptoms due to the common cold
- runny nose
- sneezing

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 an enlarged prostate gland

Ask a doctor or pharmacist

before use if you are taking sedatives or tranquilizers

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

If pregnant or breast-feeding

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Take every 4-6 hours
Do not take more than 6 doses in 24 hours

adults and children 12 years of age and over	Take 1 capsule (50 mg)
children under 12 years of age	ask a doctor, the proper dosage strength is not available in this package**
**Do not attempt to break capsules. The proper dosage strength and dosing information for children under 12 years of age is available on the 25 mg package.

Other Information

Store at room temperature, USP.
Do not use if either capsule band or imprinted safety seal under cap is broken or missing
Protect from moisture
Contains lactose

Inactive Ingredients

D&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Lactose and Starch.

Questions?

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Distributed by

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

PRINCIPAL DISPLAY PANEL

DRUG: Banophen

GENERIC: diphenhydramine hcl

DOSAGE: CAPSULE

ADMINSTRATION: ORAL

NDC: 70518-1289-0

NDC: 70518-1289-1

COLOR: pink

SHAPE: CAPSULE

SCORE: No score

SIZE: 14 mm

IMPRINT: CPC;836

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 10 in 1 BOTTLE PLASTIC

ACTIVE INGREDIENT(S):

DIPHENHYDRAMINE HYDROCHLORIDE 50mg in 1

INACTIVE INGREDIENT(S):

D&C RED NO. 28
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN
LACTOSE MONOHYDRATE
STARCH, CORN

INGREDIENTS AND APPEARANCE

BANOPHEN

diphenhydramine hcl capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70518-1289(NDC:0904-5307)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	50 mg

Ingredient Name	Strength
Inactive Ingredients
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	pink	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	CPC;836
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70518-1289-0	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	08/09/2018
2	NDC:70518-1289-1	10 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/26/2019	06/16/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	08/09/2018

Labeler - REMEDYREPACK INC. (829572556)

Revised: 9/2022

Document Id: e8a781d1-e992-2cd4-e053-2a95a90adc4e

Set id: 28a98e8d-98c9-4e7c-b978-b567cb280f94

Version: 7

Effective Time: 20220914