DIPHENHYDRAMINE HCL- diphenhydramine hcl liquid 
Akron Pharma 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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Akron Pharma, Inc.

Active ingredient (in each teaspoonful (5 mL))

Diphenhydramine HCl 12.5 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
  • 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

  • avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • use caution when driving a motor vehicle or operating machinery

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

AgeDose
adults and children 12 years and over2 - 4 teaspoonsful (25 mg to 50 mg)
children 6 to 11 years1 - 2 teaspoonsful (12.5 mg to 25 mg)
children 2 to 5 yearsdo not use unless directed by a doctor
children under 2 yearsdo not use


Other information

Inactive ingredients

Bubble Gum Flavor, Citric Acid, Purified Water, Sodium Benzoate, Sodium Citrate, Sodium Saccharin, Sorbitol Solution 70% & Sucrose.

Questions or comments?

Please Call 1(877) 225-6999

Manufactured for:
Akron Pharma, Inc,
Fairfield, NJ 07004
Manufactured in U.S.A

4oz

8oz

16oz

DIPHENHYDRAMINE HCL 
diphenhydramine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71399-0125
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
Color    Score    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71399-0125-4118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/25/2019
2NDC:71399-0125-8236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/25/2019
3NDC:71399-0125-6473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34110/25/2019
Labeler - Akron Pharma Inc. (067878881)

Revised: 2/2023
Document Id: 1180ee01-61eb-4a1b-9c1e-8ca1f5160473
Set id: 91f5fce9-f131-45f4-92a1-a6dab361cdce
Version: 5
Effective Time: 20230226
 
Akron Pharma Inc.