Children's

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (6.25 mg) Phenylephrine (2.5 mg)

Inactive Ingredients

Grape Benzoic Acid Citric Acid Monohydrate Edetate Disodium Fd&c Blue No. 1 Fd&c Red No. 40 Propylene Glycol Water Sodium Citrate Saccharin Sodium Sorbitol

Identifiers & Packaging

Pill Appearance

Color: purple

Marketing Status

OTC MONOGRAPH FINAL Active Since 2009-11-25

Medication Information

Description

NITE TIME COLD & COUGH Drug Facts

Uses

temporarily relieves
sneezing
itchy nose or throat
runny nose
itchy, watery eyes due to hay fever
nasal and sinus congestion
cough due to minor throat and bronchial irritation as may occur with a cold

Section 42229-5

NITE TIME COLD & COUGH

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.

Section 50568-5

Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers

Section 55105-1

Active ingredients (in each 5 mL, 1 teaspoonful)	Purposes
Diphenhydramine HCl 6.25 mg	Antihistamine/Cough suppressant
Phenylephrine HCl 2.5 mg	Nasal decongestant

Directions

may be given every 4 hours. Do not give more than 6 doses in 24 hours unless directed by a doctor.
to find right dose, use rotating bottle label to dose by weight; otherwise, use chart below to dose by age.
specifically designed for use with enclosed dosing spoon. Use only enclosed dosing spoon to dose this product. Do not use any other dosing device.

children under 6 years of age	do not use
children 6 to under 12 years of age	1-2 tsp. (5-10 mL)

Do Not Use

in a child under 6 years of age
in a child who is 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 the child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
with any other product containing diphenhydramine, even one used on skin
for the purpose of making your child sleepy

Questions?

877-434-2036

Other Information

each teaspoonful contains: sodium 4 mg
store at controlled room temperature 20°-25°C (68°-77°F)

Inactive Ingredients

artificial flavor, benzoic acid, citric acid, disodium edetate, FD&C blue no. 1, FD&C red no. 40, propylene glycol, purified water, sodium citrate, sodium saccharin, sorbitol.

When Using This Product

do not exceed recommended dosage
marked drowsiness may occur
sedatives and tranquilizers may increase drowsiness
excitability may occur, especially in children

Stop Use and Ask A Doctor If

nervousness, dizziness, or sleeplessness occurs
symptoms do not improve within 7 days or occur with a fever
cough persists for more than 7 days, comes back, or occurs with a fever, rash, or persistent headache. These could be signs of a serious condition.

Principal Display Panel 118 Ml Carton

CHILDREN'S

ACCUDIAL

ROTATING DOSING LABEL

Nite Time

Cold & Cough

ACCURATE DOSING

BY WEIGHT

Diphenhydramine HCl

(Antihistamine/Cough Suppressant

Phenylephrine HCl

(Nasal Decongestant)

Cough Relief

Runny, Stuffy Nose

Itchy Throat

For Ages 6 to under 12

Compares to Children's

Triaminic^® Night Time

Cold & Cough.

GRAPE

FLAVOR

4 FL. OZ.

(118 mL)

NDC 45014-154-04

Ask A Doctor Before Use If the Child Has

heart disease
high blood pressure
thyroid disease
diabetes
glaucoma
cough that occurs with too much phlegm (mucus)
chronic cough that lasts, or as occurs with asthma
a breathing problem such as chronic bronchitis

Structured Label Content

Uses

temporarily relieves
sneezing
itchy nose or throat
runny nose
itchy, watery eyes due to hay fever
nasal and sinus congestion
cough due to minor throat and bronchial irritation as may occur with a cold

Section 42229-5 (42229-5)

NITE TIME COLD & COUGH

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.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers

Section 55105-1 (55105-1)

Active ingredients (in each 5 mL, 1 teaspoonful)	Purposes
Diphenhydramine HCl 6.25 mg	Antihistamine/Cough suppressant
Phenylephrine HCl 2.5 mg	Nasal decongestant

Directions

may be given every 4 hours. Do not give more than 6 doses in 24 hours unless directed by a doctor.
to find right dose, use rotating bottle label to dose by weight; otherwise, use chart below to dose by age.
specifically designed for use with enclosed dosing spoon. Use only enclosed dosing spoon to dose this product. Do not use any other dosing device.

children under 6 years of age	do not use
children 6 to under 12 years of age	1-2 tsp. (5-10 mL)

Do Not Use (Do not use)

in a child under 6 years of age
in a child who is 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 the child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
with any other product containing diphenhydramine, even one used on skin
for the purpose of making your child sleepy

Questions?

877-434-2036

Other Information (Other information)

each teaspoonful contains: sodium 4 mg
store at controlled room temperature 20°-25°C (68°-77°F)

Inactive Ingredients (Inactive ingredients)

artificial flavor, benzoic acid, citric acid, disodium edetate, FD&C blue no. 1, FD&C red no. 40, propylene glycol, purified water, sodium citrate, sodium saccharin, sorbitol.

When Using This Product (When using this product)

do not exceed recommended dosage
marked drowsiness may occur
sedatives and tranquilizers may increase drowsiness
excitability may occur, especially in children

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

nervousness, dizziness, or sleeplessness occurs
symptoms do not improve within 7 days or occur with a fever
cough persists for more than 7 days, comes back, or occurs with a fever, rash, or persistent headache. These could be signs of a serious condition.

Principal Display Panel 118 Ml Carton (PRINCIPAL DISPLAY PANEL - 118 mL Carton)

CHILDREN'S

ACCUDIAL

ROTATING DOSING LABEL

Nite Time

Cold & Cough

ACCURATE DOSING

BY WEIGHT

Diphenhydramine HCl

(Antihistamine/Cough Suppressant

Phenylephrine HCl

(Nasal Decongestant)

Cough Relief

Runny, Stuffy Nose

Itchy Throat

For Ages 6 to under 12

Compares to Children's

Triaminic^® Night Time

Cold & Cough.

GRAPE

FLAVOR

4 FL. OZ.

(118 mL)

NDC 45014-154-04

Ask A Doctor Before Use If the Child Has (Ask a doctor before use if the child has)

heart disease
high blood pressure
thyroid disease
diabetes
glaucoma
cough that occurs with too much phlegm (mucus)
chronic cough that lasts, or as occurs with asthma
a breathing problem such as chronic bronchitis

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves sneezing itchy nose or throat runny nose itchy, watery eyes due to hay fever nasal and sinus congestion cough due to minor throat and bronchial irritation as may occur with a cold", "42229-5": "NITE TIME COLD & COUGH 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.", "50568-5": "Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers", "55105-1": "Active ingredients (in each 5 mL, 1 teaspoonful) Purposes Diphenhydramine HCl 6.25 mg Antihistamine/Cough suppressant Phenylephrine HCl 2.5 mg Nasal decongestant", "Directions": "may be given every 4 hours. Do not give more than 6 doses in 24 hours unless directed by a doctor. to find right dose, use rotating bottle label to dose by weight; otherwise, use chart below to dose by age. specifically designed for use with enclosed dosing spoon. Use only enclosed dosing spoon to dose this product. Do not use any other dosing device. children under 6 years of age do not use children 6 to under 12 years of age 1-2 tsp. (5-10 mL)", "Do not use": "in a child under 6 years of age in a child who is 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 the child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. with any other product containing diphenhydramine, even one used on skin for the purpose of making your child sleepy", "Questions?": "877-434-2036", "Other information": "each teaspoonful contains: sodium 4 mg store at controlled room temperature 20°-25°C (68°-77°F)", "Inactive ingredients": "artificial flavor, benzoic acid, citric acid, disodium edetate, FD&C blue no. 1, FD&C red no. 40, propylene glycol, purified water, sodium citrate, sodium saccharin, sorbitol.", "When using this product": "do not exceed recommended dosage marked drowsiness may occur sedatives and tranquilizers may increase drowsiness excitability may occur, especially in children", "Stop use and ask a doctor if": "nervousness, dizziness, or sleeplessness occurs symptoms do not improve within 7 days or occur with a fever cough persists for more than 7 days, comes back, or occurs with a fever, rash, or persistent headache. These could be signs of a serious condition.", "PRINCIPAL DISPLAY PANEL - 118 mL Carton": "CHILDREN'S ACCU DIAL ROTATING DOSING LABEL Nite Time Cold & Cough ACCURATE DOSING BY WEIGHT Diphenhydramine HCl (Antihistamine/Cough Suppressant Phenylephrine HCl (Nasal Decongestant) Cough Relief Runny, Stuffy Nose Itchy Throat For Ages 6 to under 12 Compares to Children's Triaminic ® Night Time Cold & Cough. GRAPE FLAVOR 4 FL. OZ. (118 mL) NDC 45014-154-04", "Ask a doctor before use if the child has": "heart disease high blood pressure thyroid disease diabetes glaucoma cough that occurs with too much phlegm (mucus) chronic cough that lasts, or as occurs with asthma a breathing problem such as chronic bronchitis"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information