NITE TIME COLD AND COUGH- diphenhydramine hydrochloride and phenylephrine hydrochloride solution

Nite Time Cold and Cough by

Drug Labeling and Warnings

Nite Time Cold and Cough by is a Otc medication manufactured, distributed, or labeled by Accudial Pharmaceutical, Inc., Bio-Pharm, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

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.

Warnings

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.

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.

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

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.

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

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.

Questions?

877-434-2036

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

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

ACCUDIAL®
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)

INGREDIENTS AND APPEARANCE

NITE TIME COLD AND COUGH 
diphenhydramine hydrochloride and phenylephrine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45014-159
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M)	Diphenhydramine Hydrochloride	6.25 mg  in 5 mL
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV)	Phenylephrine Hydrochloride	2.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
Benzoic Acid (UNII: 8SKN0B0MIM)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Edetate Disodium (UNII: 7FLD91C86K)
FD&C Blue No. 1 (UNII: H3R47K3TBD)
FD&C Red No. 40 (UNII: WZB9127XOA)
Propylene Glycol (UNII: 6DC9Q167V3)
Water (UNII: 059QF0KO0R)
Sodium Citrate (UNII: 1Q73Q2JULR)
Saccharin Sodium (UNII: SB8ZUX40TY)
Sorbitol (UNII: 506T60A25R)

Product Characteristics
Color	PURPLE	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 45014-159-04	118 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	02/01/2013

Labeler - Accudial Pharmaceutical, Inc. (831999201)

Establishment
Name	Address	ID/FEI	Business Operations
Bio-Pharm, Inc.		801652546	ANALYSIS(45014-159) , MANUFACTURE(45014-159) , RELABEL(45014-159) , REPACK(45014-159)