ALLERGY CHILDRENS- diphenhydramine hydrochloride liquid

Allergy by

Drug Labeling and Warnings

Allergy by is a Otc medication manufactured, distributed, or labeled by We Care Distributors Inc., Purine Pharma. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 5 mL)*

Diphenhydramine HCl 12.5 mg

*5 mL = 1 teaspoon (tsp)

Purpose

Antihistamine

Uses

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

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 you have

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

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 or tranquilizers may increase drowsiness
• be careful when operating 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

• take every 4 - 6 hours
• do not take more than 6 times in 24 hours

• Age (yr):

  Dose

• Adult and children 12 years of age and over:

  10-20 mL

  (25 to 50 mg)

• Children 6 to under 12 years of age:

  5-10 mL

  (12.5 to 25 mg)

• Children under 6 years of age:

  Ask a doctor

Other information

• store at room temperature 15-30°C (59-86°F)
• protect from freezing
• protect from light
• each teaspoon (5 mL) contains: sodium 16 mg

Inactive ingredients

citric acid, D&C red #33, FD&C red #40, flavor, glycerin, high fructose corn syrup, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sodium sacchrin, sorbitol, sucrose

Questions or comments?

1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com

Principal Display Panel

Compare to the active ingredient in Children’s Benadryl® Allergy Liquid

See New Warnings and Directions

CHILDREN'S ALLERGY

LIQUID MEDICATION

DIPHENHYDRAMINE HCl

ORAL SOLUTION

ANTIHISTAMINE

Relieves: Sneezing, Runny nose, Itchy, watery eyes, Itchy throat

Cherry Flavored

Alcohol Free

INGREDIENTS AND APPEARANCE

ALLERGY  CHILDRENS
diphenhydramine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70005-036
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
POLOXAMER 407 (UNII: TUF2IVW3M2)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SUCROSE (UNII: C151H8M554)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	RED (Bluish-Red)	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70005-036-01	1 in 1 CARTON	06/21/2016
1		120 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/21/2016

Labeler - We Care Distributors Inc. (079832998)

Establishment
Name	Address	ID/FEI	Business Operations
Purine Pharma		019950491	manufacture(70005-036)