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

Childrens Triacting Nighttime Cold and Cough by

Drug Labeling and Warnings

Childrens Triacting Nighttime Cold and Cough 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 mL, 1 teaspoonful)

Diphenhydramine HCl 6.25 mg

Phenylephrine HCl 2.5 mg

Purposes

Antihistamine/Cough suppressant

Nasal decongestant 

Uses

• temporarily relieves:
  • sneezing
  • running 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

• to make a child sleepy 
• 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

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 use more than directed
• 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 take more than 6 doses in any 24-hour period
• measure only with dosing cup provided
• keep dosing cup with product
• tsp = teaspoon, mL = milliliter

• age: dose
• children 6 to 11 years: 2 tsp (10 mL) every 4 hours
• children 4 to 5 years: do not use unless directed by a doctor
• children under 4 years: do not use

Other information

• each 5 mL contains: sodium 6 mg
• contains no aspirin
• protect from light
• store at 20º-25°C (68º-77°F). Do not refrigerate.

Inactive ingredients

acesulfame potassium, alcohol, benzoic acid, citric acid, disodium EDTA,Fd&C blue #1,  FD&C red #40, maltitol solution, natural & artificial flavor, propylene glycol, purified water, sodium citrate

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 Consumer Health, Inc., distributors of Children's Triaminic® Night Time Cold & Cough.

TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL ON THE 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

Questions:248-449-9300

Package Label

 

Childrens Triacting Nighttime Cold and Cough

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: 63868-368
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)
BENZOIC ACID (UNII: 8SKN0B0MIM)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C RED NO. 40 (UNII: WZB9127XOA)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
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: 63868-368-04	1 in 1 BOX	05/30/2014	12/30/2021
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	05/30/2014	12/30/2021

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