Nite Time Cold And Cough
FDA Label NDC 45014-159

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Accudial Pharmaceutical, Inc. for the product Nite Time Cold And Cough (NDC 45014-159). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, uses, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, when using this product, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Otc - Purpose

→ Uses

→ Otc - Do Not Use

→ Otc - Ask Doctor

→ Otc - Ask Doctor/pharmacist

→ When Using This Product

→ Otc - Stop Use

→ Otc - Keep Out Of Reach Of Children

→ Overdose Warning

→ Other Information

→ Directions

→ Inactive Ingredients

→ Questions?

→ Principal Display Panel - 118 Ml Bottle Label

Other

Drug Facts

Distributed by: AccuDial® Pharmaceutical, Inc.
Palm Beach Gardens, FL 33408

Otc - Purpose

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

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.

Otc - 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.

Otc - Ask Doctor

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.

Otc - Ask Doctor/Pharmacist

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

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)
TSP = teaspoon
under 6 yrs.	ask a doctor
6 to under 12	2 TSP
or as directed by a doctor

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.

Otc - Stop Use

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.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

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.

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.

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.