DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride capsule 
REMEDYREPACK 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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0835&0836(box unit)-Major

Active Ingredient (in each banded capsule)

Diphenhydramine HCl… 25 mg

Diphenhydramine HCl… 50 mg

Purpose

Antihistamine

Use

25 MG

  • 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

50 MG

  • Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies and common cold
    • sneezing
    • runny nose
    • itchy, watery eyes
    • itchy throat and nose

WARNINGS

Do not use

25 MG

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

50 MG

  • to make a child sleepy
  • with any other product containing diphenhydramine, including one applied topically

Ask a doctor before use if you have

25 MG

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

50 MG

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • 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 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

25 MG

adults and children 12 years of age and over1 to 2 capsules
children 6 years to under 12 years of age1 capsule
children under 6 years of agedo not use this product in children under 6 years of age

50 MG

adults and children 12 years of age and over1 capsule
children 6 years to under 12 years of ageAsk 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 20°C – 25°C (68°F – 77°F); excursions permitted to 15° – 30°C (59° – 86°F) [See USP Controlled Room Temperature]
  • Protect from moisture
  • Contains lactose

Inactive Ingredients

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

Questions?

Questions or comments? (800) 616-2471

Distributed by

Repackaged and Distributed By:

Remedy Repack, Inc.

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

PRINCIPAL DISPLAY PANEL

DRUG: Diphenhydramine Hydrochloride

GENERIC: Diphenhydramine Hydrochloride

DOSAGE: CAPSULE

ADMINSTRATION: ORAL

NDC: 70518-1680-0

NDC: 70518-1680-1

NDC: 70518-1680-2

NDC: 70518-1680-3

NDC: 70518-1680-4

NDC: 70518-1680-5

NDC: 70518-1680-6

COLOR: pink

SHAPE: CAPSULE

SCORE: No score

SIZE: 14 mm

IMPRINT: CPC;835

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 20 in 1 BOTTLE PLASTIC

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 100 in 1 BOX

PACKAGING: 1 in 1 POUCH

PACKAGING: 100 in 1 BOX

PACKAGING: 1 in 1 POUCH

ACTIVE INGREDIENT(S):

  • DIPHENHYDRAMINE HYDROCHLORIDE 25mg 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

Remedy_Label

MM2

MM3

MM4

MM5

MM6

MM7

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-1680(NDC:0904-5306)
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
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
Colorpink (half pink and half clear with white powder inside) Scoreno score
ShapeCAPSULESize14mm
FlavorImprint Code CPC;835
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70518-1680-030 in 1 BLISTER PACK; Type 0: Not a Combination Product11/20/2018
2NDC:70518-1680-120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/04/2020
3NDC:70518-1680-230 in 1 BLISTER PACK; Type 0: Not a Combination Product03/04/2020
4NDC:70518-1680-3100 in 1 BOX08/05/2021
4NDC:70518-1680-41 in 1 POUCH; Type 0: Not a Combination Product
5NDC:70518-1680-5100 in 1 BOX10/13/2021
5NDC:70518-1680-61 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/20/2018
Labeler - REMEDYREPACK INC. (829572556)

Revised: 10/2021
 
REMEDYREPACK INC.