Childrens Triacting Night Time Cold and Cough by AmerisourceBergen (Good Neighbor Pharmacy) 46122 Drug Facts

Childrens Triacting Night Time Cold and Cough by

Drug Labeling and Warnings

Childrens Triacting Night Time Cold and Cough by is a Otc medication manufactured, distributed, or labeled by AmerisourceBergen (Good Neighbor Pharmacy) 46122. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CHILDRENS TRIACTING NIGHT TIME COLD AND COUGH- diphenhydramine hcl, phenylephrine hcl liquid 
AmerisourceBergen (Good Neighbor Pharmacy) 46122

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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Drug Facts

Active ingredients (in each 5 mL)

Diphenhydramine HCl 6.25 mg

Phenylephrine HCI 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 irritations 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 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
  • 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 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
  • excitability may occur, especially in children
  • sedatives and tranquilizers may increase drowsiness

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 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.
  • measure only with dosing cup provided Do not use any other dosing device
  • keep dosing cup with product
  • mL=mililiter
AgeDose 
 children 6 to under 12 years 10 mL every 4 hours
 children 4 to under 6 yearsdo not use unless directed by a doctor
 children under 4 years do not use 

Other Information

  • each 5 mL contains: sodium 3 mg
  • store between 20º-25ºC (68º-77ºF). Do not refrigerate.
  • protect from light

Inactive ingredients

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

Questions or comments?

 Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Children's

Triacting Night Time

Cold & Cough

Diphenhydramine HCl/ Antihistamine/Cough Suppressant

Phenylephrine HCl/Nasal Decongestant

  • cough
  • itchy throat
  • runny nose
  • stuffy nose

Grape flavor

for ages 6 to 11

Compare to Children's Triaminic® Night Time Cold & cough active ingredients*

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

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

DOSAGE CUP PROVIDED

FL OZ (mL)

Distributed by AmerisourceBergen

1300 Morris Drive, Chesterbrook, PA 19087

www.mygnp.com

Package Label

Diphenhydramine HCl 6.25 mg, Phenylephrine HCl 2.5 mg

Good Neighor Pharmacy Childrens Triacting Nigh Time

CHILDRENS TRIACTING NIGHT TIME COLD AND COUGH 
diphenhydramine hcl, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 46122-302
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)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
MALTITOL (UNII: D65DG142WK)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 46122-302-261 in 1 BOX09/30/201512/31/2019
1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34109/30/201512/31/2019
Labeler - AmerisourceBergen (Good Neighbor Pharmacy) 46122 (007914906)

Revised: 12/2018
 
AmerisourceBergen (Good Neighbor Pharmacy) 46122