DIPHENHYDRAMINE- diphenhydramine hydrochloride capsule 
Safetec of America, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient (in each capsule)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

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
  • 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. (1-800-222-1222)

Directions

adults and children 12 years and over 1 to 2 capsules
children 6 to under 12 years 1 capsule
children under 6 years do not use

Other information

Inactive ingredients

benzyl alcohol, butyl paraben, D&C red #28, edible black ink, FD&C blue #1, FD&C red #40, gelatin, lactose, magnesium stearate, methyl paraben, polysorbate 80, propyl paraben, sodium lauryl sulfate

Questions or comments?

Call toll free: 1-800-456-7077

Principal Display Panel - 25 mg Pouch Label

Safetec
of America, Inc.

DO NOT USE IF POUCH IS TORN OR DAMAGED

Manufactured for Safetec of America, Inc.
Buffalo NY 14215

Allergy Relief

Diphenhydramine HCl

antihistamine 2 Capsules

Principal Display Panel - 25 mg Pouch Label

Principal Display Panel – 50 Pouches Carton Label

Safetec®
of America, Inc.

*Compare to the active ingredient in Benadryl®

NDC 61010-4409-1

Allergy Relief

Diphenhydramine HCl 25 mg

PUSH TO OPEN

Dispense through opening

Antihistamine

TAMPER EVIDENT UNIT DOSE POUCHES

DO NOT USE IF POUCH IS TORN OR DAMAGED

50 Pouches 2 Capsules per pouchPrincipal Display Panel – 50 Pouches Carton Label
Graphic-Untitled

Principal Display Panel – 100 Pouches Carton Label

Safetec®
of America, Inc.

*Compare to the active ingredient in Benadryl®

NDC 61010-4409-2

Allergy Relief

Diphenhydramine HCl 25 mg – Antihistamine

PUSH TO OPEN

Dispense through opening

TAMPER EVIDENT UNIT DOSE POUCHES

DO NOT USE IF POUCH IS TORN OR DAMAGED

100 Pouches 2 Capsules per pouch

Principal Display Panel – 100 Pouches Carton Label
DIPHENHYDRAMINE 
diphenhydramine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-4409
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M) Diphenhydramine Hydrochloride25 mg
Inactive Ingredients
Ingredient NameStrength
benzyl alcohol (UNII: LKG8494WBH)  
butylparaben (UNII: 3QPI1U3FV8)  
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, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
Product Characteristics
Colorpink (PINK) , white ( WHITE) Scoreno score
ShapeOVAL (OVAL) Size14mm
FlavorImprint Code AP;20
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61010-4409-02 in 1 POUCH; Type 0: Not a Combination Product12/30/2019
2NDC:61010-4409-150 in 1 BOX12/30/2019
2NDC:61010-4409-02 in 1 POUCH; Type 0: Not a Combination Product
3NDC:61010-4409-2100 in 1 BOX12/30/2019
3NDC:61010-4409-02 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/30/2019
Labeler - Safetec of America, Inc. (874965262)

Revised: 1/2020
Document Id: 89099217-6a54-40a1-bfce-8bb6bc55ca5c
Set id: ef6b86cc-bfc5-4e74-a806-33de9a68ce45
Version: 2
Effective Time: 20200127
 
Safetec of America, Inc.