TRIACTING DAY TIME WITH PE- dextromethorphan hydrobromide, phenylephrine hydrochloride liquid 
Safeway, 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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Drug Facts

Active ingredients (in each 5 mL, 1 teaspoon)

Dextromethorphan HBr 5 mg

Phenylephrine HCI 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 your 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 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
agedose 
 children 6 to 11 years 2 tsp (10 mL) every 4 hours 
 children 4 to 5 years 1 tsp (5 mL) every 4 hours 
 children under 4 years do not use 

Other Information

  • each 5 mL contains: sodium 2 mg
  • store at 20º-25ºC (68º-77ºF). Do not refrigerate.
  • contains no aspirin

Inactive ingredients

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

Principal Display Panel

AGES 4-11 YEARS

Daytime Children's

Cold & Cough Relief

Dextromethorphan HBr 5 mg - Cough Suppressant

Phenylephrine HCI 2.5 mg - Nasal Decongestant

Cherry Flavor

Compare to Children's Triaminic® Day Time Cold & Cough active ingredients*

  • Relief of: Cough & stuffy nose
  • Alcohol 0.14%
  • Dosing cup included

FL OZ (mL)

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

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

DISTRIBUTED BY SAFEWAY INC.

P.O. BOX 99, PLEASANTON, CA 94566-0009

1-888-SAFEWAY   www.safeway.com

PARENTS: Learn about teen medicine abuse   www.StopMedicineAbuse.org

Package Label

Dextromethorphan HBr 5 mg, Phenylephrine HCl 2.5 mg

Safeway Children's Daytime Cold & Cough Relief Cherry Liquid

 

TRIACTING DAY TIME  WITH PE
dextromethorphan hydrobromide, phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-148
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)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
MALTITOL (UNII: D65DG142WK)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (Cherry Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21130-148-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/02/200904/02/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34104/02/200904/02/2020
Labeler - Safeway, Inc. (009137209)

Revised: 7/2019
Document Id: 57abfbd7-b9e2-4de6-9112-cd269d08380b
Set id: 4ada9596-cef9-4c28-b2cc-1c1dee6033f7
Version: 6
Effective Time: 20190709
 
Safeway, Inc.