CHILDRENS TRIACTING- diphenhydramine hcl, phenylephrine hcl solution 
Western Family Foods Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Western Family Children’s Triacting Drug Facts

Active ingredients (in each 5 mL, 1 teaspoon)

Diphenhydramine HCl, USP 6.25 mg

Phenylephrine HCl, USP 2.5 mg

Purpose

Antihistamine/cough suppressant

Nasal decongestant

Uses

temporarily relieves
itchy, watery eyes due to hay fever
sneezing
nasal and sinus congestion
runny nose
itchy nose or throat
cough due to minor throat and bronchial irritation

Warnings

Do not use

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 your 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
to make a child sleepy

Ask a doctor before use if the child has

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

Ask a doctor or pharmacist before use if the child is

taking sedatives or tranquilizers

When using this product

do not exceed recommended dosage
may cause marked drowsiness
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 get better within 7 days or occur with fever
cough lasts for more than 7 days, comes back, or occurs with fever, rash or headache that lasts. A persistent cough may be a sign of a serious condition.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

take every 4 hours; not to exceed 6 doses in 24 hours or as directed by a doctor

children 6 to under 12 years of age

2 teaspoons (tsp)

children 4 to under 6 years of age

do not use unless directed by a doctor

children under 4 years of age

do not use

Other information

each teaspoon contains: sodium 3 mg
store at 20º-25ºC (68º-77ºF)

Inactive ingredients

acesulfame potassium, anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavor, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate

Principal Display Panel

Children’s

Triacting

Night Time Cold & Cough

ANTIHISTAMINE, COUGH SUPPRESSANT (DIPHENHYDRAMINE HCl)

NASAL DECONGESTANT (PHENYLEPHRINE HCl)

Cough Relief

Runny, Stuffy Nose

Itchy Throat

See New Warning and Dosing Directions

GRAPE FLAVOR

COMPARE TO TRIAMINIC® NIGHT TIME COLD & COUGH active ingredients

4 FL OZ (118 mL)

Western Family Children's Triacting Image 1
Western Family Children's Triacting Image 2
CHILDRENS TRIACTING 
diphenhydramine hcl, phenylephrine hcl solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-913
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE6.25 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
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 BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55312-913-261 in 1 CARTON08/30/200712/14/2017
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/30/200712/14/2017
Labeler - Western Family Foods Inc (192166072)

Revised: 11/2017
 
Western Family Foods Inc