Childrens allergy plus congestion relief solution

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
  • stuffy nose
  • itching of the nose or throat
  • nasal congestion
  • itchy, watery eyes
  • 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 Parkinsons 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
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

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 20-25C (68-77F). 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

Ingredients and appearance - Product information

Childrens allergy plus congestion relief solution- Diphenhydramine hcl, phenylephrine hcl

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 11822-1119
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Diphenhydramine hydrochloride ( UNII: TC2D6JAD40)( Diphenhydramine - UNII: 8GTS82S83M ) 12.5 mgin 5 mL
Phenylephrine hydrochloride ( UNII: 04JA59TNSJ)( Phenylephrine - UNII: 1WS297W6MV ) 5 mgin 5 mL

Inactive Ingredients

Ingredient Name Code
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) Flavor GRAPE

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part341 USA

Labeler - Rite Aid Corporation( 014578892)

Package/label principal display panel

Compare to the active ingredients of Childrens Benadryl ®Allergy Plus Congestion

6 YEARS & OLDER

CHILDRENS ALLERGY PLUS CONGESTION RELIEF

alcohol free - oral solution

DIPHENHYDRAMINE HCl 12.5 mg

ANTIHISTAMINE

PHENYLEPHRINE HCl 5 mg

NASAL DECONGESTANT

for relief of:

sneezing, runny, itchy or stuffy nose

itchy, watery eyes

itchy throat sinus congestion

GRAPE FLAVOR

DOSAGE CUP INCLUDED

4 FL OZ (118 mL)