Childrens Benadryl Allergy Plus Congestion

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (12.5 mg) Phenylephrine (5 mg)

Inactive Ingredients

Anhydrous Citric Acid Carboxymethylcellulose Sodium, Unspecified Edetate Disodium Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Water Sodium Benzoate Sodium Citrate, Unspecified Form Sorbitol Solution Sucralose

Identifiers & Packaging

Pill Appearance

Color: purple

Marketing Status

OTC MONOGRAPH DRUG Active Since 2014-09-30

Medication Information

Description

Drug Facts

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

Section 42229-5

Drug Facts

Section 50565-1

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)

Section 50568-5

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

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

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

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.

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.

Other Information

each 5 mL contains: sodium 10 mg
store between 20-25°C (68-77°F)
do not use if carton tape or bottle wrap imprinted with "Sealed For Your Safety" 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)

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

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

Structured Label Content

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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)

Section 50568-5 (50568-5)

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

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

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

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.

Do Not Use (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.

Other Information (Other information)

each 5 mL contains: sodium 10 mg
store between 20-25°C (68-77°F)
do not use if carton tape or bottle wrap imprinted with "Sealed For Your Safety" is broken or missing

Inactive Ingredients (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? (Questions or comments?)

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

Principal Display Panel (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)

When Using This Product (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 (Stop use and ask a doctor if)

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

Ask A Doctor Before Use If You Have (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

Advanced Ingredient Data

[{"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED", "unii": "K679OBS311", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE DISODIUM", "unii": "7FLD91C86K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CITRATE, UNSPECIFIED FORM", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL SOLUTION", "unii": "8KW3E207O2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "12.5", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "PHENYLEPHRINE", "unii": "1WS297W6MV", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"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", "42229-5": "Drug Facts", "50565-1": "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)", "50568-5": "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Active ingredients (in each 5 mL) Purposes Diphenhydramine HCl 12.5 mg Antihistamine Phenylephrine HCl 5 mg Nasal decongestant", "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.", "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.", "Other information": "each 5 mL contains: sodium 10 mg store between 20-25°C (68-77°F) do not use if carton tape or bottle wrap imprinted with "Sealed For Your Safety" 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)", "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", "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"}

Childrens Benadryl Allergy Plus Congestion

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information