CHILDRENS ALLERGY- diphenhydramine hydrochloride liquid 
AptaPharma Inc.

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Drug Facts       


Active ingredient                   
(in each 5 mL teaspoon)

Diphenhydramine HCL 12.5 mg

Purpose

Antihistamine

Uses
■ Temporarily relieves these symptoms
due to hay fever or other respiratory allergies:
   ■ sneezing
   ■ itching of the nose or throat
   ■ runny nose
   ■ itchy watery eyes
■ temporarily relieves these symptoms due to
the common cold:
   ■ sneezing
   ■ runny nose

Warnings
Do not use ■ with any other product containing
diphenhydramine, even one used on skin
■ to make a child sleepy

Ask a doctor before use if the child has
■ glaucoma
■ abreathing problem such as chronic bronchitis

Ask a doctor or pharmacist before use if the
child is taking sedatives or tranquilizers

When using this product

■ marked drowsiness may occur
■ excitability may occur, especially in children
■ sedatives and tranquilizers may increase
   drowsiness

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

Directions■ if needed, take every 4-6 hours■ do not take more than 6 doses in 24 hours

Children under 4 years of age: do not use
Children 4 to under 6 years of age: do not use unless
 directed by a doctor
Children 6 to under 12 years of age: 1 to 2 teaspoonfuls
 (12.5 mg to 25 mg)

Other Information

■ Keep carton for full directions for use
■ each teaspoonful contains: sodium 10 mg
■ store at 20° - 25° C(68° - 77° F)
■ dosage cup provided

Inactive ingredients
Citric acid, D&C Red # 33, FD&C Red # 40, flavor,
glycerin, poloxamer 407, purified water, sodium
benzoate, sodium chloride, sodium citrate, sucrose

Questions or comments? Call weekdays
from 9:30 AM to 4:30 PM EST at 1-877-798-5944.

Product Label

AP SAFE                                NDC 72681-505-24

COMPARE TO THE
ACTIVE INGREDIENT IN
CHILDREN'S BENADRYL®
ALLERGY LIQUID*

Children's
Allergy
Relief

DIPHENHYDRAMINE HCl
Liquid
Antihistamine

Relieves: Sneezing,
Runny Nose,
Itchy Watery Eyes,
Itchy Throat

• Alcohol-Free

4 FL OZ (118 mL)             Cherry Flavor

DO NOT USE IF PRINTED SEAL
UNDER CAP IS TORN OR MISSING

      2
1013430
   3/20

*This product is not manufactured or
distributed by McNeil PPC, Inc., distributor
of Benadryl® Allergy liquid.

Manufactured by:
AptaPharma Inc.,
1533 Union Ave.
Pennsauken, NJ 08110

AP-BX-03

Carton

505-24 Box

Bottle

505-24 Btl

res

CHILDRENS ALLERGY 
diphenhydramine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76281-505
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76281-505-24118 mL in 1 BOTTLE; Type 0: Not a Combination Product09/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01209/30/2020
Labeler - AptaPharma Inc. (790523323)
Registrant - AptaPharma Inc. (790523323)
Establishment
NameAddressID/FEIBusiness Operations
AptaPharma Inc.790523323manufacture(76281-505)

Revised: 12/2023
Document Id: e5ea2a3e-b957-4469-b0ee-b0c5af3cb417
Set id: b2cef61f-ab54-4a20-a7f7-6d3da4754e8b
Version: 4
Effective Time: 20231230
 
AptaPharma Inc.