TRIACTING DAY TIME COLD AND COUGH CHILDRENS- dextromethorphan hbr, phenylephrine hcl liquid 
Care One (American Sales Company)

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)

Dextromethorphan HBr 5 mg

Phenylephrine HCl 2.5 mg

Purposes

Cough suppressant

Nasal decongestant 

Uses

  • temporarily relieves:
    • 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.

Ask a doctor before use if the child has

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

When using this product,

do not use more than directed.

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. Do not use any other dosing device
  • keep dosing cup with product
  • mL = milliliter
  • shake well before using
 age dose
 children 6 to under 12 years of age 10 mL every 4 hours
 children 4 to 5 years 5 mL every 4 hours
 children under 4 years do not use

Other information

  • each 5 mL contains: sodium 2 mg
  • store at 20º-25°C (68º-77°F). Do not refrigerate.

Inactive ingredients

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

Questions or comments?

Call 1-888-723-3929 Monday-Friday 7AM-6PM PST

Principal Display Panel

For Ages 4 to 11

Children's Triacting Day Time Cold and Cough

Dextromethorphan HBr -Cough suppressant

Phenylephrine HCl-Nasal decongestant

Compare to active ingredients in Triaminic® DayTime Cold & Cough*

Relieves:

  • Stuffy nose
  • Cough

Cherry Flavor

FL OZ (mL)

*This product is not manufactured or distributed by Novartis Consumer Health, Inc., distributors of Children's Triaminic® DayTime Cold & Cough.

DISTRIBUTED BY

FOODHOLD USA, LLC

LANDOVER, MD 20785

1-877-846-9949

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

Package Label

Dextromethorphan HBr 5 mg, Phenylephrine HCl 2.5 mg

Care One Children's Triacting Day Time Cold and Cough

TRIACTING DAY TIME COLD AND COUGH  CHILDRENS
dextromethorphan hbr, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-378
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 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)  
ALCOHOL (UNII: 3K9958V90M)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
MALTITOL (UNII: D65DG142WK)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-378-041 in 1 BOX06/30/201512/29/2023
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 finalpart34106/30/201512/29/2023
Labeler - Care One (American Sales Company) (809183973)

Revised: 10/2021
Document Id: 91e65d0c-2deb-4cdc-9aa2-debb9e482988
Set id: 242ee7d3-9977-41bb-88b2-a4ad81e316be
Version: 3
Effective Time: 20211008
 
Care One (American Sales Company)