CHILDRENS TRIACTING NIGHTTIME COLD AND COUGH- diphenhydramine hcl, phenylephrine hcl liquid

Childrens Triacting Nighttime by

Drug Labeling and Warnings

Childrens Triacting Nighttime by is a Otc medication manufactured, distributed, or labeled by QUALITY CHOICE (Chain Drug Marketing Association). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 5 m)

Diphenhydramine HCl 6.25 mg

Phenylephrine HCl 2.5 mg

Purposes

Antihistamine/Cough suppressant

Nasal decongestant 

Uses

• temporarily relieves:
  • sneezing
  • runny nose
  • itchy nose or throat
  • 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 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.
• 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

• glaucoma
• heart disease
• high blood pressure
• diabetes
• thyroid disease
• a breathing problem such as chronic bronchitis
• chronic cough that lasts, or as occurs with asthma
• cough that occurs with too much phlegm (mucus)

Ask a doctor or 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.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

• Do not give more than 6 doses in 24 hours unless directed by a doctor.
• mL = milliliter
• measure only with dosing cup provided. Do not use any other dosing device.
• keep dosing cup with product

• Age: Dose
• children 6 to under 12 years: 10 mL every 4 hours
• children 4 to under 6 years: do not use unless directed by a doctor
• children under 4 years of age: do not use

Other information

• each 5 mL contains: sodium 3 mg
• store at 20-25°C (68-77°F) Do not refrigerate
• protect from light

Inactive ingredients

acesulfame potassium, anhydrous citric acid, EDTA disodium, FD&C blue #1, FD&C red #40, flavor, maltitol, propylene glycol, purified water, sodium benzoate, trisodium citrate dihydrate

Questions or comments?

Call 1-248-449-9300 Monday-Friday 9AM-5PM EST 

Principal Display Panel

*Compare to the active ingredients in Children's Triaminic® Nighttime Cold & Cough

Children's Triacting Nighttime

Cold & Cough

Diphenhydramine HCl

Antihistamine

Cough Suppressant

Phenylephrine HCl

Nasal Decongestant

For Ages 6 to 11

Grape Flavor

FL OZ (mL)

*This product is not manufactured or distributed by Novartis distributors of Children's Triaminic® Night Time Cold & Cough.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER THE CAP IS BROKEN OR MISSING.

Distributed by C.D.M.A., Inc.©

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Package Label

Quality Choice Children's Triacting Nighttime Cold & Cough Liquid

INGREDIENTS AND APPEARANCE

CHILDRENS TRIACTING NIGHTTIME  COLD AND COUGH
diphenhydramine hcl, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-301
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C RED NO. 40 (UNII: WZB9127XOA)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
MALTITOL (UNII: D65DG142WK)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-301-04	1 in 1 BOX	11/30/2014	12/31/2020
1		118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	11/30/2014	12/31/2020

Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)