BANOPHEN- diphenhydramine hcl tablet

Banophen by

Drug Labeling and Warnings

Banophen by is a Otc medication manufactured, distributed, or labeled by REMEDYREPACK INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  
  • runny nose
  • itchy, watery eyes
  • sneezing
  • itching of the nose or throat

• 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

• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• difficulty in urination due to enlargement of the 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 beverages
  
• alcohol, sedatives, and tranquilizers may increase drowsiness
• use caution 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 (1-800-222-1222) right away.

Directions

• take every 4 to 6 hours, or as directed by a doctor
• do not take more than 6 times in 24 hours

• adults and children 12 years and over: 1 to 2 tablets
• children 6 to under 12 years: 1 tablet
• children under 6 years: do not use

Other information

• each tablet contains: calcium 30 mg
• TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  
• store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
• protect from moisture
• see end flap for expiration date and lot number 

Inactive ingredients

corn starch, D&C red #27 aluminum lake, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide

PRINCIPAL DISPLAY PANEL

DRUG: Banophen

GENERIC: Diphenhydramine HCl

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-0285-0

NDC: 70518-0285-1

NDC: 70518-0285-2

NDC: 70518-0285-3

COLOR: pink

SHAPE: OVAL

SCORE: No score

SIZE: 11 mm

IMPRINT: 44;329

PACKAGING: 20 in 1 BOTTLE, PLASTIC

PACKAGING: 200 in 1 BOTTLE PLASTIC

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 100 in 1 BOTTLE PLASTIC

ACTIVE INGREDIENT(S):

• DIPHENHYDRAMINE HYDROCHLORIDE 25mg in 1

INACTIVE INGREDIENT(S):

• CELLULOSE, MICROCRYSTALLINE
• TITANIUM DIOXIDE
• STARCH, CORN
• POLYVINYL ALCOHOL, UNSPECIFIED
• STEARIC ACID
• SILICON DIOXIDE
• CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
• D&C RED NO. 27
• POLYETHYLENE GLYCOL, UNSPECIFIED
• MAGNESIUM STEARATE
• TALC

INGREDIENTS AND APPEARANCE

BANOPHEN 
diphenhydramine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70518-0285(NDC:0904-5551)
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
D&C RED NO. 27 (UNII: 2LRS185U6K)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STARCH, CORN (UNII: O8232NY3SJ)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	pink	Score	no score
Shape	OVAL	Size	11mm
Flavor		Imprint Code	44;329
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70518-0285-0	20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/06/2017	03/07/2018
2	NDC: 70518-0285-1	200 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/03/2017	04/04/2018
3	NDC: 70518-0285-2	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	12/12/2017	03/31/2020
4	NDC: 70518-0285-3	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/01/2018	02/06/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/06/2017	03/31/2020

Labeler - REMEDYREPACK INC. (829572556)