CHILDRENS ALLERGY- diphenhydramine hydrochloride liquid

ACTIVE INGREDIENT

Drug Facts

Active ingredient
(in each 5 mL teaspoon)

Diphenhydramine HCL 12.5 mg
PURPOSE

Purpose

Antihistamine
INDICATIONS & USAGE

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

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

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

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

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

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

DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION

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 INGREDIENT

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

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

Bottle

res

INGREDIENTS AND APPEARANCE

CHILDRENS ALLERGY
diphenhydramine hydrochloride liquid

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 76281-505-24	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/30/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M012	09/30/2020

Labeler - AptaPharma Inc. (790523323)

Registrant - AptaPharma Inc. (790523323)

Name	Address	ID/FEI	Business Operations
Establishment
AptaPharma Inc.		790523323	manufacture(76281-505)

Childrens Allergy by