Active Ingredients (In Each 5 Ml)
Dextromethorphan HBr 5 mg
Phenylephrine HCl 2.5 mg
Triacting Daytime Cold Cough Syrup
FDA Label NDC 21130-378
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Safeway, Inc. for the product Triacting Daytime Cold Cough (NDC 21130-378). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each 5 ml), purposes, uses, do not use, ask a doctor before use if the child has, when using this product,, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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 20°-25°C (68°-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
Daytime Children's
Cold & Cough Relief
Dextromethorphan HBr 5 mg-Cough suppressant
Phenylephrine HCl 2.5 mg-Nasal decongestant
Compare to active ingredients in Children's Triaminic® DayTime Cold & Cough* active ingredients*
- Relief of: cough & stuffy nose
- Alcohol 0.14%
- Dosing cup included
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
BETTER LIVING BRANDS LLC
P.O. BOX 99, PLEASANTON, CA
94566-0009
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP BROKEN OR MISSING.
Package Label
Signature Care Daytime Children's Cold & Cough Relief
* Please review the disclaimer below.
