Nite Time Cold & Cough

Nite Time Cold & Cough
SPL v1
SPL
SPL Set ID b41f9c5b-8671-43f0-acd1-1b21051246ec
Route
ORAL
Published
Effective Date 2013-02-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

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

Description

Drug Facts


Medication Information

Description

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

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
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)


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)

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
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 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.

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


Raw Label Data

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