nite time cold & cough

Drug Facts

Composition & Product

Active Ingredients

diphenhydramine (6.25 mg) phenylephrine (2.5 mg)

Inactive Ingredients

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 2013-02-01

Medication Information

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.

Directions

may be given every 4 hours
do not use more than 6 times in 24 hours
use only enclosed dosing cup to dose this product. Do not use any other dosing device.

Other Information

each teaspoon contains: sodium 9 mg
store between 20°-25°C (68°-77°F)
tamper evident: do not use if foil seal over the mouth of the bottle is torn, broken, or missing.

Inactive Ingredients

artificial flavor, benzoic acid, citric acid, EDTA disodium dihydrate, FD&C blue #1, FD&C red #40, propylene glycol, purified water, sodium citrate, sodium saccharin, sorbitol.

Description

Drug Facts

Questions?

877-434-2036

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50566-9

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.

Section 50568-5

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

Section 50569-3

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.

Section 50570-1

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.

Section 55105-1

Active ingredient (in each 5 mL = 1 teaspoon)	Purpose
Diphenhydramine HCl, USP 6.25 mg	Antihistamine/Cough suppressant
Phenylephrine HCl, USP 2.5 mg	Nasal decongestant

Overdose Warning

Taking more than the recommended dose (overdose) may cause liver damage. In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Prompt medical attention is critical, even if you do not notice any signs or symptoms.

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.

Principal Display Panel 118 Ml Bottle Label

ACCU DIAL _®

Children's

Nite Time

Cold and Cough

Diphenhydramine

(Antihistamine/Cough Suppressant)

Phenylephrine HCl (Nasal Decongestant)

Relieves Cough • Runny Nose

Stuffy Nose • Itchy Throat

Earth-Friendly

Package!

For Ages 6 yrs to under 12 yrs

Tamper Evident

Compares to Children's Triaminic^®

Night Time Cold & Cough

GRAPE

FLAVOR

NDC 45014-159-04

4 FL. OZ. (118 mL)

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.

Directions

may be given every 4 hours
do not use more than 6 times in 24 hours
use only enclosed dosing cup to dose this product. Do not use any other dosing device.

Other Information (Other information)

each teaspoon contains: sodium 9 mg
store between 20°-25°C (68°-77°F)
tamper evident: do not use if foil seal over the mouth of the bottle is torn, broken, or missing.

Inactive Ingredients (Inactive ingredients)

artificial flavor, benzoic acid, citric acid, EDTA disodium dihydrate, FD&C blue #1, FD&C red #40, propylene glycol, purified water, sodium citrate, sodium saccharin, sorbitol.

Questions?

877-434-2036

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

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.

Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

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.

Section 50570-1 (50570-1)

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.

Section 55105-1 (55105-1)

Active ingredient (in each 5 mL = 1 teaspoon)	Purpose
Diphenhydramine HCl, USP 6.25 mg	Antihistamine/Cough suppressant
Phenylephrine HCl, USP 2.5 mg	Nasal decongestant

Overdose Warning (Overdose warning)

Taking more than the recommended dose (overdose) may cause liver damage. In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Prompt medical attention is critical, even if you do not notice any signs or symptoms.

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.

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

ACCU DIAL _®

Children's

Nite Time

Cold and Cough

Diphenhydramine

(Antihistamine/Cough Suppressant)

Phenylephrine HCl (Nasal Decongestant)

Relieves Cough • Runny Nose

Stuffy Nose • Itchy Throat

Earth-Friendly

Package!

For Ages 6 yrs to under 12 yrs

Tamper Evident

Compares to Children's Triaminic^®

Night Time Cold & Cough

GRAPE

FLAVOR

NDC 45014-159-04

4 FL. OZ. (118 mL)

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": "Drug Facts", "50565-1": "Keep out of reach of children.", "50566-9": "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.", "50568-5": "Ask a pharmacist before use if the child is taking sedatives or tranquilizers.", "50569-3": "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.", "50570-1": "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.", "55105-1": "Active ingredient (in each 5 mL = 1 teaspoon) Purpose Diphenhydramine HCl, USP 6.25 mg Antihistamine/Cough suppressant Phenylephrine HCl, USP 2.5 mg Nasal decongestant", "Directions": "may be given every 4 hours do not use more than 6 times in 24 hours use only enclosed dosing cup to dose this product. Do not use any other dosing device.", "Questions?": "877-434-2036", "Overdose warning": "Taking more than the recommended dose (overdose) may cause liver damage. In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Prompt medical attention is critical, even if you do not notice any signs or symptoms.", "Other information": "each teaspoon contains: sodium 9 mg store between 20°-25°C (68°-77°F) tamper evident: do not use if foil seal over the mouth of the bottle is torn, broken, or missing.", "Inactive ingredients": "artificial flavor, benzoic acid, citric acid, EDTA disodium dihydrate, FD&C blue #1, FD&C red #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.", "PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label": "ACCU DIAL ® Children's Nite Time Cold and Cough Diphenhydramine (Antihistamine/Cough Suppressant) Phenylephrine HCl (Nasal Decongestant) Relieves Cough • Runny Nose Stuffy Nose • Itchy Throat Earth-Friendly Package! For Ages 6 yrs to under 12 yrs Tamper Evident Compares to Children's Triaminic ® Night Time Cold & Cough GRAPE FLAVOR NDC 45014-159-04 4 FL. OZ. (118 mL)"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information