CHILDRENS BENADRYL ALLERGY PLUS CONGESTION- diphenhydramine hydrochloride and phenylephrine hydrochloride solution

Childrens Benadryl Allergy Plus Congestion by

Drug Labeling and Warnings

Childrens Benadryl Allergy Plus Congestion by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 5 mL)	Purposes
Diphenhydramine HCl 12.5 mg	Antihistamine
Phenylephrine HCl 5 mg	Nasal decongestant

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
  • nasal congestion
  • stuffy nose
• temporarily relieves these symptoms due to the common cold:
  • runny nose
  • sneezing
  • nasal congestion
  • stuffy nose
• temporarily relieves sinus congestion and pressure

Warnings

Do not use

• to make a child sleepy
• with any other product containing diphenhydramine, even one used on skin
• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland
• a breathing problem such as emphysema or chronic bronchitis
• glaucoma

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

• do not exceed recommended dose
• 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

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• symptoms do not improve within 7 days or occur with a fever

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

• find right dose on chart below
• mL = milliliter
• take every 4 hours
• do not take more than 6 doses in 24 hours

Age (yr)	Dose (mL)
children under 4 years	do not use
children 4 to 5 years	do not use unless directed by a doctor
children 6 to 11 years	5 mL
adults and children 12 years and over	10 mL

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other information

• each 5 mL contains: sodium 10 mg
• store between 20-25°C (68-77°F). Protect from light.
  Store in outer carton until contents are used.
• do not use if bottle wrap or foil inner seal imprinted with "SAFETY SEAL®" is broken or missing

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Questions or comments?

call 1-877-717-2824 (toll-free) or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL

NDC: 50580-341-01

Children's
Benadryl®

ALLERGY PLUS
CONGESTION

Diphenhydramine HCl / antihistamine
Phenylephrine HCl / nasal decongestant
oral solution

4 Hours/Dose

RELIEF OF:

• ✓ Runny Nose
• ✓ Sneezing
• ✓ Itchy, Watery Eyes
• ✓ Itchy Throat or Nose
• ✓ Sinus Congestion
• ✓ Stuffy Nose

Alcohol Free
Sugar Free

ALLERGY + CONGESTION RELIEF

Grape!
Flavored Liquid

4 fl oz (118 mL)

INGREDIENTS AND APPEARANCE

CHILDRENS BENADRYL ALLERGY PLUS CONGESTION 
diphenhydramine hydrochloride and phenylephrine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50580-341
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
Phenylephrine hydrochloride (UNII: 04JA59TNSJ) (phenylephrine - UNII:1WS297W6MV)	Phenylephrine hydrochloride	5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
anhydrous citric acid (UNII: XF417D3PSL)
carboxymethylcellulose sodium, unspecified form (UNII: K679OBS311)
edetate disodium (UNII: 7FLD91C86K)
FD&C blue no. 1 (UNII: H3R47K3TBD)
FD&C red no. 40 (UNII: WZB9127XOA)
glycerin (UNII: PDC6A3C0OX)
water (UNII: 059QF0KO0R)
sodium benzoate (UNII: OJ245FE5EU)
sodium citrate, unspecified form (UNII: 1Q73Q2JULR)
sorbitol (UNII: 506T60A25R)
sucralose (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	PURPLE	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50580-341-01	1 in 1 CARTON	09/30/2014
1		118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	09/30/2014

Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)