CHILDRENS ALLERGY PLUS CONGESTION- diphenhydramine hcl, phenylephrine hcl solution

Childrens Allergy Plus Congestion by

Drug Labeling and Warnings

Childrens Allergy Plus Congestion by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 5 mL)

Diphenhydramine HCl 12.5 mg

Phenylephrine HCl 5 mg

Purpose

Antihistamine

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 at 20-25°C (68-77°F). Protect from light. Store in outer carton until contents are used.
• do not use if printed neckband is broken or missing

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, edetate disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol solution

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to the active ingredients in Children’s Benadryl® Allergy Plus Congestion

Children’s Allergy Plus Congestion

ORAL SOLUTION

DIPHENHYDRAMINE HCl

Antihistamine

PHENYLEPHRINE HCl

Nasal decongestant

Relief of:

Sneezing; Runny nose; Itchy, watery eyes; Itchy throat or nose; Sinus congestion; Stuffy nose

Grape Flavored

Alcohol Free

Actual Bottle Size on Side Panel

4 FL OZ (118 mL)

INGREDIENTS AND APPEARANCE

CHILDRENS ALLERGY PLUS CONGESTION 
diphenhydramine hcl, phenylephrine hcl solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-291
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 (UNII: K679OBS311)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-291-26	1 in 1 CARTON	06/05/2018
1		118 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	06/05/2018

Labeler - CVS Pharmacy (062312574)