Daytime Cough & Cold

Drug Facts

Composition & Product

Active Ingredients

Dextromethorphan (5 mg) Phenylephrine (2.5 mg)

Inactive Ingredients

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

Identifiers & Packaging

Pill Appearance

Color: red

Marketing Status

OTC MONOGRAPH FINAL Active Since 2013-02-01

Medication Information

Description

Drug Facts

Uses

Temporarily relieves

nasal and sinus congestion
cough due to minor throat and bronchial irritation as may occur with a cold.

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

Consult your pharmacist or health care provider for any appropriate, additional dosage delivery device necessary for use when a physician recommends a dose that is different than the doses that appear on the dosage delivery device that accompanies this product.

Age (yr)	Dose (TSP)
under 4 yrs.	ask a doctor
4 to under 6	1 TSP
6 to under 12	2 TSP
or as directed by a doctor
TSP = teaspoon

Section 50569-3

Ask a doctor before use if the child has heart disease

high blood pressure
thyroid disease
diabetes
cough that occurs with too much phlegm (mucus)
chronic cough that lasts, or as occurs with asthma.

Section 50570-1

Do not use in a child under 4 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.

Section 55105-1

Active ingredient (in each 5 mL = 1 teaspoon)	Purpose
Dextromethorphan HBr, USP 5 mg	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 2 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 red #40, propylene glycol, purified water, sodium citrate, sodium saccharin, sorbitol.

When Using This Product

do not exceed recommended dosage.

Principal Display Panel 118 Ml Bottle Label

ACCU DIAL _®

Children's

Daytime

Cough and Cold

Dextromethorphan HBr (Cough Suppressant)

Phenylephrine HCl (Nasal Decongestant)

Relieves Cough • Stuffy Nose

Earth-Friendly

Package!

For Ages 4 yrs to under 12 yrs

Tamper Evident

Compares to Children's Triaminic ^®

Day Time Cold & Cough

CHERRY

FLAVOR

NDC 45014-158-04

4 FL. OZ. (118 mL)

Structured Label Content

Uses

Temporarily relieves

nasal and sinus congestion
cough due to minor throat and bronchial irritation as may occur with a cold.

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)

Consult your pharmacist or health care provider for any appropriate, additional dosage delivery device necessary for use when a physician recommends a dose that is different than the doses that appear on the dosage delivery device that accompanies this product.

Age (yr)	Dose (TSP)
under 4 yrs.	ask a doctor
4 to under 6	1 TSP
6 to under 12	2 TSP
or as directed by a doctor
TSP = teaspoon

Section 50569-3 (50569-3)

Ask a doctor before use if the child has heart disease

high blood pressure
thyroid disease
diabetes
cough that occurs with too much phlegm (mucus)
chronic cough that lasts, or as occurs with asthma.

Section 50570-1 (50570-1)

Do not use in a child under 4 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.

Section 55105-1 (55105-1)

Active ingredient (in each 5 mL = 1 teaspoon)	Purpose
Dextromethorphan HBr, USP 5 mg	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 (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 (Other information)

each teaspoon contains: sodium 2 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 red #40, propylene glycol, purified water, sodium citrate, sodium saccharin, sorbitol.

When Using This Product (When using this product)

do not exceed recommended dosage.

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

ACCU DIAL _®

Children's

Daytime

Cough and Cold

Dextromethorphan HBr (Cough Suppressant)

Phenylephrine HCl (Nasal Decongestant)

Relieves Cough • Stuffy Nose

Earth-Friendly

Package!

For Ages 4 yrs to under 12 yrs

Tamper Evident

Compares to Children's Triaminic ^®

Day Time Cold & Cough

CHERRY

FLAVOR

NDC 45014-158-04

4 FL. OZ. (118 mL)

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "Temporarily relieves 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": "Consult your pharmacist or health care provider for any appropriate, additional dosage delivery device necessary for use when a physician recommends a dose that is different than the doses that appear on the dosage delivery device that accompanies this product. Age (yr) Dose (TSP) under 4 yrs. ask a doctor 4 to under 6 1 TSP 6 to under 12 2 TSP or as directed by a doctor TSP = teaspoon", "50569-3": "Ask a doctor before use if the child has heart disease high blood pressure thyroid disease diabetes cough that occurs with too much phlegm (mucus) chronic cough that lasts, or as occurs with asthma.", "50570-1": "Do not use in a child under 4 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.", "55105-1": "Active ingredient (in each 5 mL = 1 teaspoon) Purpose Dextromethorphan HBr, USP 5 mg 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 2 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 red #40, propylene glycol, purified water, sodium citrate, sodium saccharin, sorbitol.", "When using this product": "do not exceed recommended dosage.", "PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label": "ACCU DIAL ® Children's Daytime Cough and Cold Dextromethorphan HBr (Cough Suppressant) Phenylephrine HCl (Nasal Decongestant) Relieves Cough • Stuffy Nose Earth-Friendly Package! For Ages 4 yrs to under 12 yrs Tamper Evident Compares to Children's Triaminic ® Day Time Cold & Cough CHERRY FLAVOR NDC 45014-158-04 4 FL. OZ. (118 mL)"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information