Label: TRIACTING DAYTIME COLD COUGH CHILDRENS- dextromethorphan hbr, phenylephrine hcl syrup
- NDC Code(s): 21130-378-04
- Packager: Safeway, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated November 11, 2022
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- Official Label (Printer Friendly)
- Active ingredients (in each 5 mL)
- Purposes
- Uses
-
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
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- cough that occurs with too much phlegm (mucus)
- chronic cough that lasts, or as occurs with asthma
-
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 6 years of age 5 mL every 4 hours children under 4 years of age do not use - Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
Compare to Children's Triaminic® Day Time Cold & Cough active ingredients*
Children's Daytime
Cold & Cough Relief
FOR AGES 4-11 YEARS
Dextromethorphan HBr 5 mg-Cough suppressant
Phenylephrine HCl 2.5 mg-Nasal decongestant
- Relief of: Cough, stuffy nose
- Alcohol 0.14%
- Dosing cup included
CHERRY FLAVOR
FL OZ (mL)
*This product is not manufactured or distributed by GSK Consumer Health, distributors of Children's Triaminic® DayTime Cold & Cough.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING
DISTRIBUTED BY
BETTER LIVING BRANDS LLC
P.O. BOX 99, PLEASANTON, CA
94566-0009
- Package Label
-
INGREDIENTS AND APPEARANCE
TRIACTING DAYTIME COLD COUGH CHILDRENS
dextromethorphan hbr, phenylephrine hcl syrupProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-378 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 5 mg in 5 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg in 5 mL Inactive Ingredients Ingredient Name Strength 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) SODIUM CITRATE (UNII: 1Q73Q2JULR) Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21130-378-04 1 in 1 BOX 05/31/2015 1 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 05/31/2015 Labeler - Safeway, Inc. (009137209)